Medical Devices; Exemption From Premarket Notification Requirements; Class I Devices; Technical Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 890, and 892

[Docket No. 01N-0073]

Medical Devices; Exemption From Premarket Notification Requirements; Class I Devices; Technical Amendment

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA) is amending the language in its medical device classification regulations for class I devices for consistency, to include in sections where it was not present, a specific reference to the limitations on exemptions from premarket notification requirements for each generic device classified. The specific reference language was included when some class I generic devices were first exempted under provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA). These amendments will provide the same reference for devices that were exempted before that time. The language is intended to conveniently provide the reference, and make the sections clear and easy to read. The status of the devices is not being changed.

DATES:

This rule is effective July 25, 2001.

FOR FURTHER INFORMATION CONTACT:

Heather S. Rosecrans, Center for Devices and Radiological Health (HFZ-404), 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190.

SUPPLEMENTARY INFORMATION:

I. Background

Under section 513 of the act (21 U.S.C. 360c), FDA must classify devices into one of three regulatory classes: Class I, class II, or class III. FDA classification of a device is determined by the amount of regulation necessary to provide a reasonable assurance of safety and effectiveness. Under the 1976 amendments (Public Law 94-295), as amended by the SMDA (Public Law 101-629), devices are to be classified into class I (general controls) if there is information showing that the general controls of the act are sufficient to ensure safety and effectiveness; into class II (special controls), if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide such assurance; and into class III (premarket approval), if there is insufficient information to support classifying a device into class I or class II and the device is a life-sustaining or life-supporting device, or is for a use which is of substantial importance in preventing impairment of human health, or presents a potential unreasonable risk of illness or injury.

Most generic types of devices that were on the market before the date of the 1976 amendments (May 28, 1976) (generally referred to as preamendments devices) have been classified by FDA under the procedures set forth in section 513(c) and (d) of the act through the issuance of classification regulations into one of these three regulatory classes. Devices introduced into interstate commerce for the first time on or after May 28, 1976 (generally referred to as postamendments devices) are classified through the premarket notification process under section 510(k) of the act (21 U.S.C. 360(k)). Section 510(k) of the act and the implementing regulations in 21 CFR part 807 require persons who intend to market a new device to submit a premarket notification report (510(k)) containing information that allows FDA to determine whether the new device is substantially equivalent within the meaning of section 513(i) of the act to a legally marketed device that does not require premarket approval. Unless exempted from premarket notification requirements, persons may not market a new device under section 510(k) of the act, unless they receive a substantial equivalence order from FDA or an order reclassifying the device into class I or class II, under section 513(f) of the act.

On November 21, 1997, the President signed FDAMA into law (Public Law 105-115). Section 206 of FDAMA, in part, added a new section 510(l) to the act. New section 510(l) of the act became effective February 19, 1998. It provides that a class I device is exempt from the premarket notification requirements under section 510(k) of the act, unless the device is intended for a use that is of substantial importance in preventing impairment of human health or it presents a potential unreasonable risk of illness or injury.

To implement this provision, FDA evaluated all class I devices to determine which device types should become exempt under new provision 510(l) of the act and which device types should remain subject to the requirements of 510(k) of the act. FDA then amended its classification regulations, in part, by publishing in the

Federal Register

of February 2, 1998 (63 FR 5387), a list of certain class I devices that would become exempt from 510(k) requirements on February 19, 1998, subject, however to the limitations found in each classification regulation section (e.g., 21 CFR 862.9, 864.9, etc.), 63 FR 5387, February 2, 1998. The limitations language of each classification states that if a class I or II devices is intended for a use different from that of a legally marketed device in that generic type, or if the modified device operates using a different fundamental scientific technology than that of a legally marketed device in that generic type, a new 510(k) submission and clearance is required. The limitations language also lists specific intended uses for in vitro diagnostics devices that would preclude an exemption from the requirements of 510(k). FDA issued a proposed rule in the

Federal Register

of November 12, 1998 (63 FR 63222), to designate class I devices that are exempt from the premarket notification requirements, subject to certain limitations, and to designate class I devices that remain subject to premarket notification requirements under the new statutory criteria. The designations of these devices were codified by a final rule in the

Federal Register

of January 14, 2000 (65 FR 2296).

As published in the January 14, 2000,

Federal Register

, the amendments state, in part, that the limitations in each classification regulation apply to the premarket notification exemptions for each generic device classified in each section. In addition to mentioning the limitations generally in each classification regulation, FDA noted in the

Federal Register

of January 14, 2000, publication that, for clarity and convenience, the classification section for each generic device newly exempted under section 510(l) of the act specifically states that the exemptions are subject to limitations. The agency further noted that for individual device classification sections that had been codified previously as exempt from premarket notification requirements, it would add the same subject-to-limitations language in the future. These amendments now add that language. For example, with this regulation, 21 CFR 862.1190 states that the copper test system “is exempt from the premarket notification procedures in subpart E of part 807 of this chapter

subject to the limitations in § 862.9.

” (Emphasis added.) FDA is adding this specific reference to the limitations for

consistency, clarity, and convenience. The status of the devices is not changing.

This document is published as a final rule with the effective date shown under the

DATES

section above. FDA has already established by regulation that exemptions from premarket notification are subject to certain limitations (e.g., 21 CFR 862.9). This rule merely cross-references, for clarity and convenience, in individual classification regulations the sections that establish these limitations. FDA, therefore, has determined that this final rule has no substantive impact on the public. FDA, therefore, for good cause, finds under 5 U.S.C. 553(b)(3)(B) and (d)(3) that notice and public comment are unnecessary and that this rule may take effect upon publication.

II. Environmental Impact

The agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

III. Analysis of Impacts

FDA has examined the impact of the rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as amended by subtitle D of the Small Business Regulatory Fairness Act of 1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is consistent with the regulatory philosophy and principles identified in the Executive order. In addition, this rule is not a significant regulatory action as defined by the Executive order and so is not subject to review under the Executive order.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this rule does not change the status quo for these devices, the agency certifies that this final rule will not have a significant economic impact on a substantial number of small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement of anticipated costs and benefits before proposing any rule that may result in an expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million in any one year (adjusted annually for inflation). The Unfunded Mandates Reform Act does not require FDA to prepare a statement of costs and benefits for the final rule, because the final rule is not expected to result in any 1-year expenditure that would exceed $100 million.

IV. Paperwork Reduction Act of 1995

This final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

List of Subjects

21 CFR Parts 862, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 888, and 890

Medical devices.

21 CFR Part 864

Biologics, Blood, Laboratories, Medical devices, Packaging and containers.

21 CFR Part 886

Medical devices, Ophthalmic goods and services.

21 CFR Part 892

Medical devices, Radiation protection, X-rays.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 890, and 892 are amended as follows:

PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

1. The authority citation for 21 CFR part 862 continues to read as follows:

Authority:

21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

2. Section 862.1190 is amended by revising paragraph (b) to read as follows:

§ 862.1190

Copper test system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

3. Section 862.1210 is amended by revising paragraph (b) to read as follows:

§ 862.1210

Creatine test system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

4. Section 862.1255 is amended by revising paragraph (b) to read as follows:

§ 862.1255

2,3-Diphosphoglyceric acid test system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

5. Section 862.1290 is amended by revising paragraph (b) to read as follows:

§ 862.1290

Fatty acids test system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

6. Section 862.1305 is amended by revising paragraph (b) to read as follows:

§ 862.1305

Formiminoglutamic acid (FIGLU) test system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

7. Section 862.1320 is amended by revising paragraph (b) to read as follows:

§ 862.1320

Gastric acidity test system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

8. Section 862.1365 is amended by revising paragraph (b) to read as follows:

§ 862.1365

Glutathione test system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9

9. Section 862.1380 is amended by revising paragraph (b) to read as follows:

§ 862.1380

Hydroxybutyric dehydrogenase test system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

10. Section 862.1420 is amended by revising paragraph (b) to read as follows:

§ 862.1420

Isocitric dehydrogenase test system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

11. Section 862.1470 is amended by revising paragraph (b) to read as follows:

§ 862.1470

Lipid (total) test system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

12. Section 862.1490 is amended by revising paragraph (b) to read as follows:

§ 862.1490

Lysozyme (muramidase) test system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

13. Section 862.1515 is amended by revising paragraph (b) to read as follows:

§ 862.1515

Nitrogen (amino-nitrogen) test system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

14. Section 862.1565 is amended by revising paragraph (b) to read as follows:

§ 862.1565

6-Phosphogluconate dehydrogenase test system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

15. Section 862.1575 is amended by revising paragraph (b) to read as follows:

§ 862.1575

Phospholipid test system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

16. Section 862.1640 is amended by revising paragraph (b) to read as follows:

§ 862.1640

Protein-bound iodine test system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

17. Section 862.1670 is amended by revising paragraph (b) to read as follows:

§ 862.1670

Sorbitol dehydrogenase test system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

18. Section 862.1720 is amended by revising paragraph (b) to read as follows:

§ 862.1720

Triose phosphate isomerase test system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 subject to the limitations in § 862.9.

19. Section 862.1815 is amended by revising paragraph (b) to read as follows:

§ 862.1815

Vitamin E test system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 subject to the limitations in § 862.9.

20. Section 862.2050 is amended by revising paragraph (b) to read as follows:

§ 862.2050

General purpose laboratory equipment labeled or promoted for a specific medical use.

(b)

Classification.

Class I (general controls). The device is identified in paragraph (a) of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

21. Section 862.2100 is amended by revising paragraph (b) to read as follows:

§ 862.2100

Calculator/data processing module for clinical use.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

22. Section 862.2230 is amended by revising paragraph (b) to read as follows:

§ 862.2230

Chromatographic separation material for clinical use.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

23. Section 862.2310 is amended by revising paragraph (b) to read as follows:

§ 862.2310

Clinical sample concentrator.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

24. Section 862.2320 is amended by revising paragraph (b) to read as follows:

§ 862.2320

Beta or gamma counter for clinical use.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

25. Section 862.2485 is amended by revising paragraph (b) to read as follows:

§ 862.2485

Electrophoresis apparatus for clinical use.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

26. Section 862.2720 is amended by revising paragraph (b) to read as follows:

§ 862.2720

Plasma oncometer for clinical use.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

27. Section 862.2800 is amended by revising paragraph (b) to read as follows:

§ 862.2800

Refractometer for clinical use.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

28. Section 862.2920 is amended by revising paragraph (b) to read as follows:

§ 862.2920

Plasma viscometer for clinical use.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in

subpart E of part 807 of this chapter subject to the limitations in § 862.9.

PART 864—HEMATOLOGY AND PATHOLOGY DEVICES

29. The authority citation for 21 CFR part 864 continues to read as follows:

Authority:

21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

30. Section 864.1850 is amended by revising paragraph (b) to read as follows:

§ 864.1850

Dye and chemical solution stains.

(b)

Classification.

Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. These devices are also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

31. Section 864.2220 is amended by revising paragraph (b) to read as follows:

§ 864.2220

Synthetic cell and tissue culture media and components.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

32. Section 864.2240 is amended by revising paragraph (b) to read as follows:

§ 864.2240

Cell and tissue culture supplies and equipment.

(b)

Classification.

Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. If the devices are not labeled or otherwise represented as sterile, they are exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

33. Section 864.2260 is amended by revising paragraph (b) to read as follows:

§ 864.2260

Chromosome culture kit.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

34. Section 864.2360 is amended by revising paragraph (b) to read as follows:

§ 864.2360

Mycoplasma detection media and components.

(b)

Classification.

Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

35. Section 864.2800 is amended by revising paragraph (b) to read as follows:

§ 864.2800

Animal and human sera.

(b)

Classification.

Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

36. Section 864.2875 is amended by revising paragraph (b) to read as follows:

§ 864.2875

Balanced salt solutions or formulations.

(b)

Classification.

Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

37. Section 864.3010 is amended by revising paragraph (b) to read as follows:

§ 864.3010

Tissue processing equipment.

(b)

Classification.

Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. The devices are also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

38. Section 864.3300 is amended by revising paragraph (b) to read as follows:

§ 864.3300

Cytocentrifuge.

(b)

Classification.

Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

39. Section 864.3400 is amended by revising paragraph (b) to read as follows:

§ 864.3400

Device for sealing microsections.

(b)

Classification.

Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

40. Section 864.3600 is amended by revising paragraph (b) to read as follows:

§ 864.3600

Microscopes and accessories.

(b)

Classification.

Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

41. Section 864.3800 is amended by revising paragraph (b) to read as follows:

§ 864.3800

Automated slide stainer.

(b)

Classification.

Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

42. Section 864.3875 is amended by revising paragraph (b) to read as follows:

§ 864.3875

Automated tissue processor.

(b)

Classification.

Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

43. Section 864.4010 is amended by revising paragraph (b) to read as follows:

§ 864.4010

General purpose reagent.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

44. Section 864.4400 is amended by revising paragraph (b) to read as follows:

§ 864.4400

Enzyme preparations.

(b)

Classification.

Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

45. Section 864.5350 is amended by revising paragraph (b) to read as follows:

§ 864.5350

Microsedimentation centrifuge.

(b)

Classification.

Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

46. Section 864.5800 is amended by revising paragraph (b) to read as follows:

§ 864.5800

Automated sedimentation rate device.

(b)

Classification.

Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

47. Section 864.5850 is amended by revising paragraph (b) to read as follows:

§ 864.5850

Automated slide spinner.

(b)

Classification.

Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

48. Section 864.6160 is amended by revising paragraph (b) to read as follows:

§ 864.6160

Manual blood cell counting device.

(b)

Classification.

Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

49. Section 864.6600 is amended by revising paragraph (b) to read as follows:

§ 864.6600

Osmotic fragility test.

(b)

Classification.

Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

50. Section 864.6700 is amended by revising paragraph (b) to read as follows:

§ 864.6700

Erythrocyte sedimentation rate test.

(b)

Classification.

Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

51. Section 864.7660 is amended by revising paragraph (b) to read as follows:

§ 864.7660

Leukocyte alkaline phosphatase test.

(b)

Classification.

Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

52. Section 864.7675 is amended by revising paragraph (b) to read as follows:

§ 864.7675

Leukocyte peroxidase test.

(b)

Classification.

Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

53. Section 864.7900 is amended by revising paragraph (b) to read as follows:

§ 864.7900

Thromboplastin generation test.

(b)

Classification.

Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

54. Section 864.8200 is amended by revising paragraph (b) to read as follows:

§ 864.8200

Blood cell diluent.

(b)

Classification.

Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

55. Section 864.8500 is amended by revising paragraph (b) to read as follows:

§ 864.8500

Lymphocyte separation medium.

(b)

Classification.

Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

56. Section 864.8540 is amended by revising paragraph (b) to read as follows:

§ 864.8540

Red cell lysing reagent.

(b)

Classification.

Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES

57. The authority citation for 21 CFR part 866 continues to read as follows:

Authority:

21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

58. Section 866.2050 is amended by revising paragraph (b) to read as follows:

§ 866.2050

Staphylococcal typing bacteriophage.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

59. Section 866.2120 is amended by revising paragraph (b) to read as follows:

§ 866.2120

Anaerobic chamber.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. The device is also exempt from the good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

60. Section 866.2160 is amended by revising paragraph (b) to read as follows:

§ 866.2160

Coagulase plasma.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

61. Section 866.2170 is amended by revising paragraph (b) to read as follows:

§ 866.2170

Automated colony counter.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

62. Section 866.2180 is amended by revising paragraph (b) to read as follows:

§ 866.2180

Manual colony counter.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. The device is also exempt from the good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

63. Section 866.2300 is amended by revising paragraph (b) to read as follows:

§ 866.2300

Multipurpose culture medium.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

64. Section 866.2320 is amended by revising paragraph (b) to read as follows:

§ 866.2320

Differential culture medium.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

65. Section 866.2330 is amended by revising paragraph (b) to read as follows:

§ 866.2330

Enriched culture medium.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

66. Section 866.2350 is amended by revising paragraph (b) to read as follows:

§ 866.2350

Microbiological assay culture medium.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

67. Section 866.2360 is amended by revising paragraph (b) to read as follows:

§ 866.2360

Selective culture medium.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

68. Section 866.2440 is amended by revising paragraph (b) to read as follows:

§ 866.2440

Automated medium dispensing and stacking device.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. The device is also exempt from the good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

69. Section 866.2450 is amended by revising paragraph (b) to read as follows:

§ 866.2450

Supplement for culture media.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

70. Section 866.2480 is amended by revising paragraph (b) to read as follows:

§ 866.2480

Quality control kit for culture media.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

71. Section 866.2500 is amended by revising paragraph (b) to read as follows:

§ 866.2500

Microtiter diluting and dispensing device.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

72. Section 866.2540 is amended by revising paragraph (b) to read as follows:

§ 866.2540

Microbiological incubator.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. The device is also exempt from the good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

73. Section 866.2580 is amended by revising paragraph (b) to read as follows:

§ 866.2580

Gas-generating device.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

74. Section 866.2600 is amended by revising paragraph (b) to read as follows:

§ 866.2600

Wood's fluorescent lamp.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. The device is also exempt from the good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

75. Section 866.3010 is amended by revising paragraph (b) to read as follows:

§ 866.3010

Acinetobacter calcoaceticus serological reagents.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

76. Section 866.3020 is amended by revising paragraph (b) to read as follows:

§ 866.3020

Adenovirus serological reagents.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

77. Section 866.3035 is amended by revising paragraph (b) to read as follows:

§ 866.3035

Arizona spp. serological reagents.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

78. Section 866.3065 is amended by revising paragraph (b) to read as follows:

§ 866.3065

Bordetella spp. serological reagents.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

79. Section 866.3125 is amended by revising paragraph (b) to read as follows:

§ 866.3125

Citrobacter spp. serological reagents.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

80. Section 866.3205 is amended by revising paragraph (b) to read as follows:

§ 866.3205

Echovirus serological reagents.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

81. Section 866.3250 is amended by revising paragraph (b) to read as follows:

§ 866.3250

Erysipelothrix rhusiopathiae serological reagents.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

82. Section 866.3255 is amended by revising paragraph (b) to read as follows:

§ 866.3255

Escherichia coli serological reagents.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

83. Section 866.3270 is amended by revising paragraph (b) to read as follows:

§ 866.3270

Flavobacterium spp. serological reagents.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

84. Section 866.3330 is amended by revising paragraph (b) to read as follows:

§ 866.3330

Influenza virus serological reagents.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

85. Section 866.3340 is amended by revising paragraph (b) to read as follows:

§ 866.3340

Klebsiella spp. serological reagents.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

86. Section 866.3400 is amended by revising paragraph (b) to read as follows:

§ 866.3400

Parainfluenza virus serological reagents.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

87. Section 866.3410 is amended by revising paragraph (b) to read as follows:

§ 866.3410

Proteus spp. (Weil-Felix) serological reagents.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

88. Section 866.3470 is amended by revising paragraph (b) to read as follows:

§ 866.3470

Reovirus serological reagents.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

89. Section 866.3490 is amended by revising paragraph (b) to read as follows:

§ 866.3490

Rhinovirus serological reagents.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

90. Section 866.3520 is amended by revising paragraph (b) to read as follows:

§ 866.3520

Rubeola (measles) virus serological reagents.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

91. Section 866.3630 is amended by revising paragraph (b) to read as follows:

§ 866.3630

Serratia spp. serological reagents.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

92. Section 866.3700 is amended by revising paragraph (b) to read as follows:

§ 866.3700

Staphylococcus aureus serological reagents.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

93. Section 866.3720 is amended by revising paragraph (b) to read as follows:

§ 866.3720

Streptococcus spp. exoenzyme reagents.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

94. Section 866.4100 is amended by revising paragraph (b) to read as follows:

§ 866.4100

Complement reagent.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

95. Section 866.4500 is amended by revising paragraph (b) to read as follows:

§ 866.4500

Immunoelectrophoresis equipment.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

96. Section 866.4520 is amended by revising paragraph (b) to read as follows:

§ 866.4520

Immunofluorometer equipment.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

97. Section 866.4540 is amended by revising paragraph (b) to read as follows:

§ 866.4540

Immunonephelometer equipment.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

98. Section 866.4600 is amended by revising paragraph (b) to read as follows:

§ 866.4600

Ouchterlony agar plate.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

99. Section 866.4800 is amended by revising paragraph (b) to read as follows:

§ 866.4800

Radial immunodiffusion plate.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

100. Section 866.4830 is amended by revising paragraph (b) to read as follows:

§ 866.4830

Rocket immunoelectrophoresis equipment.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

101. Section 866.4900 is amended by revising paragraph (b) to read as follows:

§ 866.4900

Support gel.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

102. Section 866.5170 is amended by revising paragraph (b) to read as follows:

§ 866.5170

Breast milk immunological test system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

103. Section 866.5220 is amended by revising paragraph (b) to read as follows:

§ 866.5220

Cohn fraction II immunological test system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

104. Section 866.5230 is amended by revising paragraph (b) to read as follows:

§ 866.5230

Colostrum immunological test system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

105. Section 866.5360 is amended by revising paragraph (b) to read as follows:

§ 866.5360

Cohn fraction IV immunological test system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

106. Section 866.5370 is amended by revising paragraph (b) to read as follows:

§ 866.5370

Cohn fraction V immunological test system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

107. Section 866.5520 is amended by revising paragraph (b) to read as follows:

§ 866.5520

Immunoglobulin G (Fab fragment specific) immunological test system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

108. Section 866.5530 is amended by revising paragraph (b) to read as follows:

§ 866.5530

Immunoglobulin G (Fc fragment specific) immunological test system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

109. Section 866.5540 is amended by revising paragraph (b) to read as follows:

§ 866.5540

Immunoglobulin G (Fd fragment specific) immunological test system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

110. Section 866.5700 is amended by revising paragraph (b) to read as follows:

§ 866.5700

Whole human plasma or serum immunological test system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

111. Section 866.5800 is amended by revising paragraph (b) to read as follows:

§ 866.5800

Seminal fluid (sperm) immunological test system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

112. Section 866.5860 is amended by revising paragraph (b) to read as follows:

§ 866.5860

Total spinal fluid immunological test system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

PART 868—ANESTHESIOLOGY DEVICES

113. The authority citation for 21 CFR part 868 continues to read as follows:

Authority:

21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

114. Section 868.1030 is amended by revising paragraph (b) to read as follows:

§ 868.1030

Manual algesimeter.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

115. Section 868.1100 is amended by revising paragraph (b) to read as follows:

§ 868.1100

Arterial blood sampling kit.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

116. Section 868.1575 is amended by revising paragraph (b) to read as follows:

§ 868.1575

Gas collection vessel.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

117. Section 868.1870 is amended by revising paragraph (b) to read as follows:

§ 868.1870

Gas volume calibrator.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

118. Section 868.1930 is amended by revising paragraph (b) to read as follows:

§ 868.1930

Stethoscope head.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

119. Section 868.1965 is amended by revising paragraph (b) to read as follows:

§ 868.1965

Switching valve (ploss).

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

120. Section 868.1975 is amended by revising paragraph (b) to read as follows:

§ 868.1975

Water vapor analyzer.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

121. Section 868.2300 is amended by revising paragraph (b) to read as follows:

§ 868.2300

Bourdon gauge flowmeter.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

122. Section 868.2320 is amended by revising paragraph (b) to read as follows:

§ 868.2320

Uncompensated thorpe tube flowmeter.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

123. Section 868.2340 is amended by revising paragraph (b) to read as follows:

§ 868.2340

Compensated thorpe tube flowmeter.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

124. Section 868.2350 is amended by revising paragraph (b) to read as follows:

§ 868.2350

Gas calibration flowmeter.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

125. Section 868.2610 is amended by revising paragraph (b) to read as follows:

§ 868.2610

Gas pressure gauge.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

126. Section 868.2620 is amended by revising paragraph (b) to read as follows:

§ 868.2620

Gas pressure calibrator.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

127. Section 868.2700 is amended by revising paragraph (b) to read as follows:

§ 868.2700

Pressure regulator.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

128. Section 868.2875 is amended by revising paragraph (b) to read as follows:

§ 868.2875

Differential pressure transducer.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

129. Section 868.2885 is amended by revising paragraph (b) to read as follows:

§ 868.2885

Gas flow transducer.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

130. Section 868. 5100 is amended by revising paragraph (b) to read as follows:

§ 868.5100

Nasopharyngeal airway.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

131. Section 868.5110 is amended by revising paragraph (b) to read as follows:

§ 868.5110

Oropharyngeal airway.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

132. Section 868.5220 is amended by revising paragraph (b) to read as follows:

§ 868.5220

Blow bottle.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

133. Section 868.5240 is amended by revising paragraph (b) to read as follows:

§ 868.5240

Anesthesia breathing circuit.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

134. Section 868.5280 is amended by revising paragraph (b) to read as follows:

§ 868.5280

Breathing tube support.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

135. Section 868.5300 is amended by revising paragraph (b) to read as follows:

§ 868.5300

Carbon dioxide absorbent.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

136. Section 868.5310 is amended by revising paragraph (b) to read as follows:

§ 868.5310

Carbon dioxide absorber.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

137. Section 868.5320 is amended by revising paragraph (b) to read as follows:

§ 868.5320

Reservoir bag.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

138. Section 868.5340 is amended by revising paragraph (b) to read as follows:

§ 868.5340

Nasal oxygen cannula.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

139. Section 868.5350 is amended by revising paragraph (b) to read as follows:

§ 868.5350

Nasal oxygen catheter.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

140. Section 868.5365 is amended by revising paragraph (b) to read as follows:

§ 868.5365

Posture chair for cardiac or pulmonary treatment.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

141. Section 868.5375 is amended by revising paragraph (b) to read as follows:

§ 868.5375

Heat and moisture condensor (artificial nose).

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

142. Section 868.5420 is amended by revising paragraph (b) to read as follows:

§ 868.5420

Ether hook.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

143. Section 868.5460 is amended by revising paragraph (b) to read as follows:

§ 868.5460

Therapeutic humidifier for home use.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

144. Section 868.5530 is amended by revising paragraph (b) to read as follows:

§ 868.5530

Flexible laryngoscope.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

145. Section 868.5540 is amended by revising paragraph (b) to read as follows:

§ 868.5540

Rigid laryngoscope.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9

146. Section 868.5550 is amended by revising paragraph (b) to read as follows:

§ 868.5550

Anesthetic gas mask.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

147. Section 868.5560 is amended by revising paragraph (b) to read as follows:

§ 868.5560

Gas mask head strap.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

148. Section 868.5570 is amended by revising paragraph (b) to read as follows:

§ 868.5570

Nonrebreathing mask.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

149. Section 868.5580 is amended by revising paragraph (b) to read as follows:

§ 868.5580

Oxygen mask.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

150. Section 868.5590 is amended by revising paragraph (b) to read as follows:

§ 868.5590

Scavenging mask.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

151. Section 868.5600 is amended by revising paragraph (b) to read as follows:

§ 868.5600

Venturi mask.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

152. Section 868.5760 is amended by revising paragraph (b) to read as follows:

§ 868.5760

Cuff spreader.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

153. Section 868.5770 is amended by revising paragraph (b) to read as follows:

§ 868.5770

Tracheal tube fixation device.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

154. Section 868.5780 is amended by revising paragraph (b) to read as follows:

§ 868.5780

Tube introduction forceps.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

155. Section 868.5790 is amended by revising paragraph (b) to read as follows:

§ 868.5790

Tracheal tube stylet.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

156. Section 868.5795 is amended by revising paragraph (b) to read as follows:

§ 868.5795

Tracheal tube cleaning brush.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

157. Section 868.5810 is amended by revising paragraph (b) to read as follows:

§ 868.5810

Airway connector.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

158. Section 868.5820 is amended by revising paragraph (b) to read as follows:

§ 868.5820

Dental protector.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

159. Section 868.5860 is amended by revising paragraph (b) to read as follows:

§ 868.5860

Pressure tubing and accessories.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

160. Section 868.5975 is amended by revising paragraph (b) to read as follows:

§ 868.5975

Ventilator tubing.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

161. Section 868.5995 is amended by revising paragraph (b) to read as follows:

§ 868.5995

Tee drain (water trap).

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

162. Section 868.6100 is amended by revising paragraph (b) to read as follows:

§ 868.6100

Anesthetic cabinet, table, or tray.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

163. Section 868.6175 is amended by revising paragraph (b) to read as follows:

§ 868.6175

Cardiopulmonary emergency cart.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

164. Section 868.6225 is amended by revising paragraph (b) to read as follows:

§ 868.6225

Nose clip.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

165. Section 868.6400 is amended by revising paragraph (b) to read as follows:

§ 868.6400

Calibration gas.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

166. Section 868.6700 is amended by revising paragraph (b) to read as follows:

§ 868.6700

Anesthesia stool.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

167. Section 868.6820 is amended by revising paragraph (b) to read as follows:

§ 868.6820

Patient position support.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

168. Section 868.6885 is amended by revising paragraph (b) to read as follows:

§ 868.6885

Medical gas yoke assembly.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

PART 870—CARDIOVASCULAR DEVICES

169. The authority citation for 21 CFR part 870 continues to read as follows:

Authority:

21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

170. Section 870.1875 is amended by revising paragraph (a)(2) to read as follows:

§ 870.1875

Stethoscope.

(a) * * *

(2)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

171. Section 870.2390 is amended by revising paragraph (b) to read as follows:

§ 870.2390

Phonocardiograph.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

172. Section 870.2600 is amended by revising paragraph (b) to read as follows:

§ 870.2600

Signal isolation system.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

173. Section 870.2620 is amended by revising paragraph (b) to read as follows:

§ 870.2620

Line isolation monitor.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

174. Section 870.2640 is amended by revising paragraph (b) to read as follows:

§ 870.2640

Portable leakage current alarm.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

175. Section 870.2810 is amended by revising paragraph (b) to read as follows.

§ 870.2810

Paper chart recorder.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

176. Section 870.3650 is amended by revising paragraph (b) to read as follows:

§ 870.3650

Pacemaker polymeric mesh bag.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

177. Section 870.3670 is amended by revising paragraph (b) to read as follows:

§ 870.3670

Pacemaker charger.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

178. Section 870.3690 is amended by revising paragraph (b) to read as follows:

§ 870.3690

Pacemaker test magnet.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

179. Section 870.3730 is amended by revising paragraph (b) to read as follows:

§ 870.3730

Pacemaker service tools.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

180. Section 870.3945 is amended by revising paragraph (b) to read as follows:

§ 870.3945

Prosthetic heart valve sizer.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

181. Section 870.4500 is amended by revising paragraph (b) to read as follows:

§ 870.4500

Cardiovascular surgical instruments.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

PART 872—DENTAL DEVICES

182. The authority citation for 21 CFR part 872 continues to read as follows:

Authority:

21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

183. Section 872.1500 is amended by revising paragraph (b) to read as follows:

§ 872.1500

Gingival fluid measurer.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

184. Section 872.1730 is amended by revising paragraph (b) to read as follows:

§ 872.1730

Electrode gel for pulp testers.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

185. Section 872.1820 is amended by revising paragraph (b) to read as follows:

§ 872.1820

Dental x-ray exposure alignment device.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

186. Section 872.1840 is amended by revising paragraph (b) to read as follows:

§ 872.1840

Dental x-ray position indicating device.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

187. Section 872.1850 is amended by revising paragraph (b) to read as follows:

§ 872.1850

Lead-lined position indicator.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

188. Section 872.1905 is amended by revising paragraph (b) to read as follows:

§ 872.1905

Dental x-ray film holder.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exceptions of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

189. Section 872.3080 is amended by revising paragraph (b) to read as follows:

§ 872.3080

Mercury and alloy dispenser.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

190. Section 872.3100 is amended by revising paragraph (b) to read as follows:

§ 872.3100

Dental amalgamator.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

191. Section 872. 3110 is amended by revising paragraph (b) to read as follows:

§ 872.3110

Dental amalgam capsule.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

192. Section 872.3130 is amended by revising paragraph (b) to read as follows:

§ 872.3130

Preformed anchor.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

193. Section 872.3140 is amended by revising paragraph (b) to read as follows:

§ 872.3140

Resin applicator.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, the device is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exceptions of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

194. Section 872.3150 is amended by revising paragraph (b) to read as follows:

§ 872.3150

Articulator.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, the device is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exceptions of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

195. Section 872.3165 is amended by revising paragraph (b) to read as follows:

§ 872.3165

Precision attachment.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

196. Section 872.3220 is amended by revising paragraph (b) to read as follows:

§ 872.3220

Facebow.

(b)

Classification.

Class I (general controls). The device is exempt from the

premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, the device is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exceptions of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

197. Section 872.3240 is amended by revising paragraph (b) to read as follows:

§ 872.3240

Dental bur.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

198. Section 872.3285 is amended by revising paragraph (b) to read as follows:

§ 872.3285

Preformed clasp.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

199. Section 872.3330 is amended by revising paragraph (b) to read as follows:

§ 872.3330

Preformed crown.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

200. Section 872.3350 is amended by revising paragraph (b) to read as follows:

§ 872.3350

Gold or stainless steel cusp.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

201. Section 872.3360 is amended by revising paragraph (b) to read as follows:

§ 872.3360

Preformed cusp.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

202. Section 872.3410 is amended by revising paragraph (b) to read as follows:

§ 872.3410

Ethylene oxide homopolymer and/or carboxymethylcellulose sodium denture adhesive.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

203. Section 872.3490 is amended by revising paragraph (b) to read as follows:

§ 872.3490

Carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt denture adhesive.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

204. Section 872.3520 is amended by revising paragraph (b) to read as follows:

§ 872.3520

OTC denture cleanser.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

205. Section 872.3530 is amended by revising paragraph (b) to read as follows:

§ 872.3530

Mechanical denture cleaner.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

206. Section 872.3580 is amended by revising paragraph (b) to read as follows:

§ 872.3580

Preformed gold denture tooth.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

207. Section 872.3670 is amended by revising paragraph (b) to read as follows:

§ 872.3670

Resin impression tray material.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

208. Section 872.3730 is amended by revising paragraph (b) to read as follows:

§ 872.3730

Pantograph.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

209. Section 872.3740 is amended by revising paragraph (b) to read as follows:

§ 872.3740

Retentive and splinting pin.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9

210. Section 872.3810 is amended by revising paragraph (b) to read as follows:

§ 872.3810

Root canal post.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

211. Section 872.3830 is amended by revising paragraph (b) to read as follows:

§ 872.3830

Endodontic paper point.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

212. Section 872.3840 is amended by revising paragraph (b) to read as follows:

§ 872.3840

Endodontic silver point.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

213. Section 872.3850 is amended by revising paragraph (b) to read as follows:

§ 872.3850

Gutta percha.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

214. Section 872.3900 is amended by revising paragraph (b) to read as follows:

§ 872.3900

Posterior artificial tooth with a metal insert.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in

subpart E of part 807 of this chapter subject to the limitations in § 872.9.

215. Section 872.3910 is amended by revising paragraph (b) to read as follows:

§ 872.3910

Backing and facing for an artificial tooth.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

216. Section 872.4130 is amended by revising paragraph (b) to read as follows:

§ 872.4130

Intraoral dental drill.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

217. Section 872.4565 is amended by revising paragraph (b) to read as follows:

§ 872.4565

Dental hand instrument.

(b)

Classification.

Class I (general controls). If the device is made of the same materials that were used in the device before May 28, 1976, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

218. Section 872.4620 is amended by revising paragraph (b) to read as follows:

§ 872.4620

Fiber optic dental light.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

219. Section 872.4630 is amended by revising paragraph (b) to read as follows:

§ 872.4630

Dental operating light.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

220. Section 872.4730 is amended by revising paragraph (b) to read as follows:

§ 872.4730

Dental injecting needle.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

221. Section 872.5410 is amended by revising paragraph (b) to read as follows:

§ 872.5410

Orthodontic appliance and accessories.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

222. Section 872.5525 is amended by revising paragraph (b) to read as follows:

§ 872.5525

Preformed tooth positioner.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

223. Section 872.6010 is amended by revising paragraph (b) to read as follows:

§ 872.6010

Abrasive device and accessories.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

224. Section 872.6030 is amended by revising paragraph (b) to read as follows:

§ 872.6030

Oral cavity abrasive polishing agent.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

225. Section 872.6050 is amended by revising paragraph (b) to read as follows:

§ 872.6050

Saliva absorber.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

226. Section 872.6100 is amended by revising paragraph (b) to read as follows:

§ 872.6100

Anesthetic warmer.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

227. Section 872.6140 is amended by revising paragraph (b) to read as follows:

§ 872.6140

Articulation paper.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

228. Section 872.6200 is amended by revising paragraph (b) to read as follows:

§ 872.6200

Base plate shellac.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

229. Section 872.6290 is amended by revising paragraph (b) to read as follows:

§ 872.6290

Prophylaxis cup.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

230. Section 872.6475 is amended by revising paragraph (b) to read as follows:

§ 872.6475

Heat source for bleaching teeth.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in

subpart E of part 807 of this chapter subject to the limitations in § 872.9.

231. Section 872.6510 is amended by revising paragraph (b) to read as follows:

§ 872.6510

Oral irrigation unit.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

232. Section 872.6570 is amended by revising paragraph (b) to read as follows:

§ 872.6570

Impression tube.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

233. Section 872.6650 is amended by revising paragraph (b) to read as follows:

§ 872.6650

Massaging pick or tip for oral hygiene.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

234. Section 872.6670 is amended by revising paragraph (b) to read as follows:

§ 872.6670

Silicate protector.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

235. Section 872.6710 is amended by revising paragraph (b) to read as follows:

§ 872.6710

Boiling water sterilizer.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

236. Section 872.6855 is amended by revising paragraph (b) to read as follows:

§ 872.6855

Manual toothbrush.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

237. Section 872.6865 is amended by revising paragraph (b) to read as follows:

§ 872.6865

Powered toothbrush.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

238. Section 872.6870 is amended by revising paragraph (b) to read as follows:

§ 872.6870

Disposable flouride tray.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

239. Section 872.6880 is amended by revising paragraph (b) to read as follows:

§ 872.6880

Preformed impression tray.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

240. Section 872.6890 is amended by revising paragraph (b) to read as follows:

§ 872.6890

Intraoral dental wax.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

PART 874—EAR, NOSE, AND THROAT DEVICES

241. The authority citation for 21 CFR part 874 continues to read as follows:

Authority:

21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

242. Section 874.1060 is amended by revising paragraph (b) to read as follows:

§ 874.1060

Acoustic chamber for audiometric testing.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

243. Section 874.1080 is amended by revising paragraph (b) to read as follows:

§ 874.1080

Audiometer calibration set.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

244. Section 874.3375 is amended by revising paragraph (b) to read as follows:

§ 874.3375

Battery-powered artificial larynx.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

245. Section 874.4140 is amended by revising paragraph (b) to read as follows:

§ 874.4140

Ear, nose, and throat bur.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

246. Section 874.4175 is amended by revising paragraph (b) to read as follows:

§ 874.4175

Nasopharyngeal catheter.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

247. Section 874.4350 is amended by revising paragraph (b) to read as follows:

§ 874.4350

Ear, nose, and throat fiberoptic light source and carrier.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

248. Section 874.4750 is amended by revising paragraph (b) to read as follows:

§ 874.4750

Laryngostroboscope.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

249. Section 874.4770 is amended by revising paragraph (b) to read as follows:

§ 874.4770

Otoscope.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9 only when used in the external ear canal.

250. Section 874.5220 is amended by revising paragraph (b) to read as follows:

§ 874.5220

Ear, nose, and throat drug administration device.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

251. Section 874.5800 is amended by revising paragraph (b) to read as follows:

§ 874.5800

External nasal splint.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

PART 876—GASTROENTEROLOGY-UROLOGY DEVICES

252. The authority citation for 21 CFR part 876 continues to read as follows:

Authority:

21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

253. Section 876.1075 is amended by revising paragraph (b)(2) to read as follows:

§ 876.1075

Gastroenterology-urology biopsy instrument.

(b) * * *

(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

254. Section 876.1500 is amended by revising paragraph (b)(2) to read as follows:

§ 876.1500

Endoscope and accessories.

(b) * * *

(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

255. Section 876.4530 is amended by revising paragraph (b) to read as follows:

§ 876.4530

Gastroenterology-urology fiberoptic retractor.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

256. Section 876.4560 is amended by revising paragraph (b) to read as follows:

§ 876.4560

Ribdam.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

257. Section 876.4590 is amended by revising paragraph (b) to read as follows:

§ 876.4590

Interlocking urethral sound.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

258. Section 876.4730 is amended by revising paragraph (b) to read as follows:

§ 876.4730

Manual gastroenterology-urology surgical instrument and accessories.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

259. Section 876.4890 is amended by revising paragraph (b)(2) to read as follows:

§ 876.4890

Urological table and accessories.

(b) * * *

(2) Class I for the manually powered table and accessories, and for stirrups for electrically powered table. The device subject to this paragraph (b)(2) is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

260. Section 876.5030 is amended by revising paragraph (b) to read as follows:

§ 876.5030

Continent ileostomy catheter.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

261. Section 876.5090 is amended by revising paragraph (b)(2) to read as follows:

§ 876.5090

Supra` urological catheter and accessories.

(b) * * *

(2) Class I for the catheter punch instrument, nondisposable cannula and trocar, and gastro-urological trocar. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

262. Section 876.5130 is amended by revising paragraph (b)(2) to read as follows:

§ 876.5130

Urological catheter and accessories.

(b) * * *

(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological

catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

263. Section 876.5250 is amended by revising paragraph (b)(2) to read as follows:

§ 876.5250

Urine collector and accessories.

(b) * * *

(2) Class I (general controls). For a urine collector and accessories not intended to be connected to an indwelling catheter, subject to the limitations in § 876.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

264. Section 876.5450 is amended by revising paragraph (b) to read as follows:

§ 876.5450

Rectal dilator.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

265. Section 876.5520 is amended by revising paragraph (b)(2) to read as follows:

§ 876.5520

Urethral dilator.

(b) * * *

(2) Class I for the urethrometer, urological bougie, filiform and filiform follower, and metal or plastic urethral sound. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

266. Section 876.5540 is amended by revising paragraph (b)(4) to read as follows:

§ 876.5540

Blood access device and accessories.

(b) * * *

(4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

267. Section 876.5820 is amended by revising paragraph (b)(2) to read as follows:

§ 876.5820

Hemodialysis system and accessories.

(b) * * *

(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

268. Section 876.5900 is amended by revising paragraph (b) to read as follows:

§ 876.5900

Ostomy pouch and accessories.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

269. Section 876.5920 is amended by revising paragraph (b) to read as follows:

§ 876.5920

Protective garment for incontinence.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records, and § 820.198, regarding complaint files.

270. Section 876.5970 is amended by revising paragraph (b) to read as follows:

§ 876.5970

Hernia support.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records, and § 820.198, regarding complaint files.

PART 878—GENERAL AND PLASTIC SURGERY DEVICES

271. The authority citation for 21 CFR continues to read as follows:

Authority:

21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

272. Section 878.1800 is amended by revising paragraph (b) to read as follows:

§ 878.1800

Speculum and accessories.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

273. Section 878.3750 is amended by revising paragraph (b) to read as follows:

§ 878.3750

External prosthesis adhesive.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

274. Section 878.3800 is amended by revising paragraph (b) to read as follows:

§ 878.3800

External aesthetic restoration prosthesis.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9. If the device is intended for use without an external prosthesis adhesive to fasten it to the body, the device is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

275. Section 878.3900 is amended by revising paragraph (b) to read as follows:

§ 878.3900

Inflatable extremity splint.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

276. Section 878.4160 is amended by revising paragraph (b) to read as follows:

§ 878.4160

Surgical camera and accessories.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

277. Section 878.4380 is amended by revising paragraph (b) to read as follows:

§ 878.4380

Drape adhesive.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

278. Section 878.4440 is amended by revising paragraph (b) to read as follows:

§ 878.4440

Eye pad.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

279. Section 878.4450 is amended by revising paragraph (b) to read as follows:

§ 878.4450

Nonabsorbable gauze for internal use.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

280. Section 878.4460 is amended by revising paragraph (b) to read as follows:

§ 878.4460

Surgeon's glove.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

281. Section 878.4470 is amended by revising paragraph (b) to read as follows:

§ 878.4470

Surgeon's gloving cream.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

282. Section 878.4635 is amended by revising paragraph (b) to read as follows:

§ 878.4635

Ultraviolet lamp for tanning.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

283. Section 878.4660 is amended by revising paragraph (b) to read as follows:

§ 878.4660

Skin marker.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

284. Section 878.4700 is amended by revising paragraph (b) to read as follows:

§ 878.4700

Surgical microscope and accessories.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

285. Section 878.4730 is amended by revising paragraph (b) to read as follows:

§ 878.4730

Surgical skin degreaser or adhesive tape solvent.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

286. Section 878.4800 is amended by revising paragraph (b) to read as follows:

§ 878.4800

Manual surgical instrument for general use.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

287. Section 878.4810 is amended by revising paragraph (b)(2) to read as follows:

§ 878.4810

Laser surgical instrument for use in general and plastic surgery and in dermatology.

(b) * * *

(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

288. Section 878.4930 is amended by revising paragraph (b) to read as follows:

§ 878.4930

Suture retention device.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

289. Section 878.4950 is amended by revising paragraph (b) to read as follows:

§ 878.4950

Manual operating table and accessories and manual operating chair and accessories.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

290. Section 878.5350 is amended by revising paragraph (b) to read as follows:

§ 878.5350

Needle-type epilator.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

291. Section 878.5900 is amended by revising paragraph (b) to read as follows:

§ 878.5900

Nonpneumatic tourniquet.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

292. Section 878.5910 is amended by revising paragraph (b) to read as follows:

§ 878.5910

Pneumatic tourniquet.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES

293. The authority citation for 21 CFR part 880 continues to read as follows:

Authority:

21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

294. Section 880.2400 is amended by revising paragraph (b) to read as follows:

§ 880.2400

Bed-patient monitor.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

295. Section 880.2700 is amended by revising paragraph (b) to read as follows:

§ 880.2700

Stand-on patient scale.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device also is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

296. Section 880.2720 is amended by revising paragraph (b) to read as follows:

§ 880.2720

Patient scale.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in

subpart E of part 807 of this chapter subject to the limitations in § 880.9.

297. Section 880.2740 is amended by revising paragraph (b) to read as follows:

§ 880.2740

Surgical sponge scale.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device also is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

298. Section 880.2900 is amended by revising paragraph (b) to read as follows:

§ 880.2900

Clinical color change thermometer.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.

299. Section 880.5075 is amended by revising paragraph (b) to read as follows:

§ 880.5075

Elastic bandage.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device also is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

300. Section 880.5110 is amended by revising paragraph (b) to read as follows:

§ 880.5110

Hydraulic adjustable hospital bed.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.

301. Section 880.5120 is amended by revising paragraph (b) to read as follows:

§ 880.5120

Manual adjustable hospital bed.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

302. Section 880.5150 is amended by revising paragraph (b) to read as follows:

§ 880.5150

Nonpowered flotation therapy mattress.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device also is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

303. Section 880.5160 is amended by revising paragraph (b) to read as follows:

§ 880.5160

Therapeutic medical binder.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

304. Section 880.5180 is amended by revising paragraph (b) to read as follows:

§ 880.5180

Burn sheet.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.

305. Section 880.5210 is amended by revising paragraph (b) to read as follows:

§ 880.5210

Intravascular catheter securement device.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.

306. Section 880.5240 is amended by revising paragraph (b) to read as follows:

§ 880.5240

Medical adhesive tape and adhesive bandage.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.

307. Section 880.5300 is amended by revising paragraph (b) to read as follows:

§ 880.5300

Medical absorbent fiber.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

308. Section 880.5510 is amended by revising paragraph (b) to read as follows:

§ 880.5510

Non-AC-powered patient lift.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.

309. Section 880.5560 is amended by revising paragraph (b) to read as follows:

§ 880.5560

Temperature regulated water mattress.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.

310. Section 880.5630 is amended by revising paragraph (b) to read as follows:

§ 880.5630

Nipple shield.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.

311. Section 880.5640 is amended by revising paragraph (b) to read as follows:

§ 880.5640

Lamb feeding nipple.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

312. Section 880.5680 is amended by revising paragraph (b) to read as follows:

§ 880.5680

Pediatric position holder.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

313. Section 880.5740 is amended by revising paragraph (b) to read as follows:

§ 880.5740

Suction snakebite kit.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.

314. Section 880.5780 is amended by revising paragraph (b)(2) to read as follows:

§ 880.5780

Medical support stocking.

(b) * * *

(2)

Classification.

Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

315. Section 880.5820 is amended by revising paragraph (b) to read as follows:

§ 880.5820

Therapeutic scrotal support.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device also is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

316. Section 880.5950 is amended by revising paragraph (b) to read as follows:

§ 880.5950

Umbilical occlusion device.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.

317. Section 880.6025 is amended by revising paragraph (b) to read as follows:

§ 880.6025

Absorbent tipped applicator.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

318. Section 880.6050 is amended by revising paragraph (b) to read as follows:

§ 880.6050

Ice bag.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

319. Section 880.6060 is amended by revising paragraph (b) to read as follows:

§ 880.6060

Medical disposable bedding.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

320. Section 880.6070 is amended by revising paragraph (b) to read as follows:

§ 880.6070

Bed board.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

321. Section 880.6080 is amended by revising paragraph (b) to read as follows:

§ 880.6080

Cardiopulmonary resuscitation board.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

322. Section 880.6085 is amended by revising paragraph (b) to read as follows:

§ 880.6085

Hot/cold water bottle.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

323. Section 880.6140 is amended by revising paragraph (b) to read as follows:

§ 880.6140

Medical chair and table.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

324. Section 880.6150 is amended by revising paragraph (b) to read as follows:

§ 880.6150

Ultrasonic cleaner for medical instruments.

(b)

Classification.

Class I. The device, including any solutions intended for use with the device for cleaning and sanitizing the instruments, is exempt from the premarket notification procedures in subpart E of part 807 of

this chapter, subject to the limitations in § 880.9.

325. Section 880.6185 is amended by revising paragraph (b) to read as follows:

§ 880.6185

Cast cover.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

326. Section 880.6190 is amended by revising paragraph (b) to read as follows:

§ 880.6190

Mattress cover for medical purposes.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

327. Section 880.6200 is amended by revising paragraph (b) to read as follows:

§ 880.6200

Ring cutter.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device also is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

328. Section 880.6230 is amended by revising paragraph (b) to read as follows:

§ 880.6230

Tongue depressor.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

329. Section 880.6250 is amended by revising paragraph (b) to read as follows:

§ 880.6250

Patient examination glove.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.

330. Section 880.6265 is amended by revising paragraph (b) to read as follows:

§ 880.6265

Examination gown.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

331. Section 880.6280 is amended by revising paragraph (b) to read as follows:

§ 880.6280

Medical insole.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.

332. Section 880.6320 is amended by revising paragraph (b) to read as follows:

§ 880.6320

AC-powered medical examination light.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.

333. Section 880.6350 is amended by revising paragraph (b) to read as follows:

§ 880.6350

Battery-powered medical examination light.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device also is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

334. Section 880.6375 is amended by revising paragraph (b) to read as follows:

§ 880.6375

Patient lubricant.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.

335. Section 880.6430 is amended by revising paragraph (b) to read as follows:

§ 880.6430

Liquid medication dispenser.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

336. Section 880.6450 is amended by revising paragraph (b) to read as follows:

§ 880.6450

Skin pressure protectors.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

337. Section 880.6730 is revised to read as follows:

§ 880.6730

Body waste receptacle.

(a)

Identification

. A body waste receptacle is a device intended for medical purposes that is not attached to the body and that is used to collect the body wastes of a bed patient.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device also is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

338. Section 880.6760 is amended by revising paragraph (b) to read as follows:

§ 880.6760

Protective restraint.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.

339. Section 880.6785 is amended by revising paragraph (b) to read as follows:

§ 880.6785

Manual patient transfer device.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

340. Section 880.6800 is amended by revising paragraph (b) to read as follows:

§ 880.6800

Washers for body waste receptacles.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device also is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

341. Section 880.6820 is amended by revising paragraph (b) to read as follows:

§ 880.6820

Medical disposable scissors.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.

342. Section 880.6900 is amended by revising paragraph (b) to read as follows:

§ 880.6900

Hand-carried stretcher.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

343. Section 880.6960 is amended by revising paragraph (b) to read as follows:

§ 880.6960

Irrigating syringe.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

344. Section 880.6970 is amended by revising paragraph (b) to read as follows:

§ 880.6970

Liquid crystal vein locator.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.

345. Section 880.6980 is amended by revising paragraph (b) to read as follows:

§ 880.6980

Vein stabilizer.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

PART 882—NEUROLOGICAL DIAGNOSTIC DEVICES

346. The authority citation for 21 CFR part 882 continues to read as follows:

Authority:

21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

347. Section 882.1030 is amended by revising paragraph (b) to read as follows:

§ 882.1030

Ataxiagraph.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

348. Section 882.1410 is amended by revising paragraph (b) to read as follows:

§ 882.1410

Electroencephalograph electrode/lead tester.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

349. Section 882.1420 is amended by revising paragraph (b) to read as follows:

§ 882.1420

Electroencephalogram (EEG) signal spectrum analyzer.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

350. Section 882.1430 is amended by revising paragraph (b) to read as follows:

§ 882.1430

Electroencephalograph test signal generator.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

351. Section 882.1525 is amended by revising paragraph (b) to read as follows:

§ 882.1525

Tuning fork.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

352. Section 882.1700 is amended by revising paragraph (b) to read as follows:

§ 882.1700

Percussor.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

353. Section 882.1925 is amended by revising paragraph (b) to read as follows:

§ 882.1925

Ultrasonic scanner calibration test block.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in

subpart E of part 807 of this chapter subject to the limitations in § 882.9.

354. Section 882.4030 is amended by revising paragraph (b) to read as follows:

§ 882.4030

Skull plate anvil.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

355. Section 882.4125 is amended by revising paragraph (b) to read as follows:

§ 882.4125

Neurosurgical chair.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

356. Section 882.4200 is amended by revising paragraph (b) to read as follows:

§ 882.4200

Clip removal instrument.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

357. Section 882.4215 is amended by revising paragraph (b) to read as follows:

§ 882.4215

Clip rack.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

358. Section 882.4325 is amended by revising paragraph (b) to read as follows:

§ 882.4325

Cranial drill handpiece (brace).

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

359. Section 882.4440 is amended by revising paragraph (b) to read as follows:

§ 882.4440

Neurosurgical headrests.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

360. Section 882.4500 is amended by revising paragraph (b) to read as follows:

§ 882.4500

Cranioplasty material forming instrument.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

361. Section 882.4525 is amended by revising paragraph (b) to read as follows:

§ 882.4525

Microsurgical instrument.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

362. Section 882.4535 is amended by revising paragraph (b) to read as follows:

§ 882.4535

Nonpowered neurosurgical instrument.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

363. Section 882.4600 is amended by revising paragraph (b) to read as follows:

§ 882.4600

Leukotome.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

364. Section 882.4900 is amended by revising paragraph (b) to read as follows:

§ 882.4900

Skullplate screwdriver.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES

365. The authority citation for 21 CFR part 884 continues to read as follows:

Authority:

21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

366. Section 884.1550 is amended by revising paragraph (b) to read as follows:

§ 884.1550

Amniotic fluid sampler (amniocentesis tray).

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

367. Section 884.1640 is amended by revising paragraph (b)(2) to read as follows:

§ 884.1640

Culdoscope and accessories.

(b) * * *

(2) Class I for culdoscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such culdoscope accessory instruments include: lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable) scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.

368. Section 884.1690 is amended by revising paragraph (b)(2) to read as follows:

§ 884.1690

Hysteroscope and accessories.

(b) * * *

(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.

369. Section 884.1700 is amended by revising paragraph (b)(2) to read as follows:

§ 884.1700

Hysteroscopic insufflator.

(b) * * *

(2) Class I for tubing and tubing/filter fits which only include accessory instruments that are not used to effect intrauterine access, e.g., hysteroscopic introducer sheaths, etc.; and single-use tubing kits used for only intrauterine insufflation. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.

370. Section 884.1720 is amended by revising paragraph (b)(2) to read as follows:

§ 884.1720

Gynecologic laparoscope and accessories.

(b) * * *

(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.

371. Section 884.1730 is amended by revising paragraph (b)(2) to read as follows:

§ 884.1730

Laparoscopic insufflator.

(b) * * *

(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.

372. Section 884.2900 is amended by revising paragraph (b) to read as follows:

§ 884.2900

Fetal stethoscope.

(b)

Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.

373. Section 884.2980 is amended by revising paragraph (a)(2) to read as follows:

§ 884.2980

Telethermographic system.

(a) * * *

(2)

Classification.

Class I (general controls). The devices subject to this paragraph (a)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.

374. Section 884.2982 is amended by revising paragraph (a)(2) to read as follows:

§ 884.2982

Liquid crystal thermographic system.

(a) * * *

(2)

Classification.

Class I (general controls). The devices subject to this paragraph (a)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.

375. Section 884.4520 is amended by revising paragraph (b) to read as follows:

§ 884.4520

Obstetric-gynecologic general manual instrument.

(b)

Classification.

Class I (general controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.

376. Section 884.4530 is amended by revising paragraph (b)(2) to read as follows:

§ 884.4530

Obstetric-gynecologic specialized manual instrument.

(b) * * *

(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.

377. Section 884.5150 is amended by revising paragraph (b) to read as follows:

§ 884.5150

Nonpowered breast pump.

(b)

Classification.

Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9, if the device is using either a bulb or telescoping mechanism which does not develop more than 250 mm Hg suction, and the device materials that contact breast or breast milk do not produce cytotoxicity, irritation, or sensitization effects.

378. Sec

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