Medical Devices; Exemption From Premarket Notification for Certain Classified Devices

SUMMARY: The Food and Drug Administration (FDA) is exempting nine

generic types of class I devices from the requirement of premarket

notification. For the exempted devices, FDA has determined that

manufacturers' submissions of premarket notifications are unnecessary

for the protection of the public health and that the agency's review of

such submissions will not advance its public health mission. The

exemptions allow the agency to make better use of its resources and

thus better serve the public. Elsewhere in this issue of the Federal

Register, FDA is publishing a withdrawal of a proposed rule to grant

exemptions from premarket notification for seven other generic types of

class I devices. Also, the agency is proposing to exempt an additional

12 generic types of class I devices from the requirement of premarket

notification. These actions are being taken under the Medical Device

Amendments of 1976.

DATES: Effective August 28, 1995. Beginning on August 28, 1995, all

device manufacturers who have 510(k) submissions pending FDA review for

devices falling within a generic category which is subject to this

rule, will receive a letter stating that the device is exempt from the

premarket notification requirements of the Federal Food, Drug, and

Cosmetic Act.

FOR FURTHER INFORMATION CONTACT: Lisa A. Rooney, Center for Devices and

Radiological Health (HFZ-84), Food and Drug Administration, 2094

Gaither Rd., Rockville, MD 20850, 301-594-4765, ext. 164.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of July 21, 1994 (59 FR 37378), FDA issued

a proposed rule to exempt 164 generic types of class I devices from the

requirement of premarket notification, with limitations. Interested

persons were given until October 19, 1994, to comment on the proposed

rule.

During the comment period, FDA received comments that questioned

the appropriateness of the proposed exemptions for a small number of

the devices. FDA also received comments requesting the agency to exempt

56 additional generic types of devices. Furthermore, during this time,

FDA reconsidered the appropriateness or scope of the proposed

exemptions for several devices included in the proposed rule. In the

Federal Register of December 7, 1994 (59 FR 63005), FDA issued a final

rule exempting from the requirement of premarket notification 148 of

the 164 generic types of class I devices included in the July 21, 1994,

proposed rule. In the preamble to the final rule, the agency stated

that, in a future Federal Register notice, it would address the

requests concerning the 56 additional devices and that it was deferring

action on the following 16 devices in order to review the comments

received and to reevaluate whether certain of the devices should be

exempted from the requirement of premarket notification. (See Table 1).

Table 1

------------------------------------------------------------------------

21 CFR Device

------------------------------------------------------------------------

862.2270........................... Thin-layer chromatography system

for clinical use.

862.2310........................... Clinical sample concentrator.

862.2320........................... Beta or gamma counter for clinical

use.

862.2485........................... Electrophoresis apparatus for

clinical use.

862.2720........................... Plasma oncometer for clinical use.

862.2800........................... Refractometer for clinical use.

862.2920........................... Plasma viscometer for clinical use.

864.2280........................... Cultured animal and human cells.

866.5570........................... Lactoferrin immunological test

system.

868.5620........................... Breathing mouthpiece.

868.5675........................... Rebreathing device.

868.5700........................... Nonpowered oxygen tent.

872.3740........................... Retentive and splinting pin.

872.3810........................... Root canal post.

872.6100........................... Anesthetic warmer.

886.5850........................... Sunglasses (nonprescription).

------------------------------------------------------------------------

After careful review of the comments and reconsideration of the

appropriateness or scope of the proposed exemptions for these devices,

the agency has concluded that for 9 of the 16 generic types of class I

devices listed in Table 1, manufacturers' submissions of premarket

notifications are unnecessary for the protection of the public health

and that the agency's review of such submissions will not advance its

public health mission. These nine devices are listed in Table 2.

Table 2

------------------------------------------------------------------------

21 CFR Device

------------------------------------------------------------------------

862.2310........................... Clinical sample concentrator.

862.2320........................... Beta or gamma counter for clinical

use.

862.2485......... Electrophoresis apparatus for

clinical use.

862.2720........................... Plasma oncometer for clinical use.

862.2800........................... Refractometer for clinical use.

862.2920........................... Plasma viscometer for clinical use.

872.3740........................... Retentive and splinting pin.

872.3810........................... Root canal post.

872.6100........................... Anesthetic warmer.

------------------------------------------------------------------------

FDA, upon reconsideration, has determined not to grant the proposed

exemptions for the following seven devices. (See Table 3).

Table 3

------------------------------------------------------------------------

21 CFR Device

------------------------------------------------------------------------

862.2270........................... Thin-layer chromatography system

for clinical use.

864.2280........................... Cultured animal and human cells.

866.5570........................... Lactoferrin immunological test

system.

868.5620........................... Breathing mouthpiece.

868.5675........................... Rebreathing device.

868.5700........................... Nonpowered oxygen tent.

886.5850........................... Sunglasses (nonprescription).

------------------------------------------------------------------------

Elsewhere in this issue of the Federal Register, FDA is publishing

a withdrawal of the proposed rule to grant exemptions from the

requirement of premarket notification for the seven devices listed

above. FDA's reasons for deciding not to exempt those seven devices are

given in that withdrawal document.

Furthermore, after reviewing the comments requesting FDA to exempt

from the requirement of premarket notification 56 additional generic

types of devices, FDA has concluded that 33 of these 56 devices should

not be exempted from the requirement. As stated below in this document,

10 of these 56 devices, along with 2 additional class I devices, are

being proposed for premarket notification exemption elsewhere in this

issue of the Federal Register. Thirteen of the 56 devices already are

exempted from the requirement of premarket notification.

II. Comments

FDA received 10 comments from trade associations, manufacturer

associations, a dental firm, a consumer products manufacturer, a

company, and a law firm. A summary of the comments and the agency's

response to them is provided below.

[[Page 38897]]

A. Comments Addressing Specific Devices

1. One comment opposed the proposed exemptions from the requirement

of premarket notification for the retentive and splinting pin

(Sec. 872.3740) and the root canal post (Sec. 872.3810). According to

this comment, premarket notification submissions are necessary to

ensure that the material used in these devices are biocompatable in

order to prevent toxicity and/or allergic reactions. The comment also

stated that, because teeth are delicate, these devices must be designed

so that no undue stress will be imparted upon the teeth. According to

this comment, exempting these devices from premarket notification would

result in substandard products being made available to dental

professionals. Another comment in favor of the exemption disagreed,

stating that it is the ``method of use and application'' of these

devices, not the design or materials used in them that is the

determining factor in the safe and effective use of these devices.

Moreover, according to this comment, data relating to these devices

demonstrate that these devices are well-known, established, safe, and

effective.

FDA has concluded that exempting these devices from the requirement

of premarket notification will not result in the marketing of

substandard devices. First, both devices have a long history of safe

use. Second, neither device has a history of adverse events. Third,

literature indicates little potential for any danger to public health.

Finally, the device identifications clearly describe the material

composition of these devices. If devices are made of materials other

than those described in the identification, they will be classified

into another generic type of device or remain in the same generic type

of device, but not be exempt from the requirements of premarket

notification.

2. A comment requested that the proposed exemption for

carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid

calcium-sodium double salt denture adhesive (Sec. 872.3490) be expanded

to include other double salts of polyvinylmethylether maleic acid,

specifically salts involving those ions that achieve the same technical

effect as calcium and sodium, i.e., iron, magnesium, zinc, and

potassium.

FDA disagrees with this comment. Although the comment refers to

carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid

calcium-sodium double salt denture adhesive (Sec. 872.3490), a class I

device, the comment is actually requesting FDA to exempt another

classified dental adhesive device, polyvinylmethylether maleic

anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium

(NACMC) denture adhesive (Sec. 872.3500) which is a class III device.

3. FDA received a comment requesting that an endolumina illuminated

bougie (EIB) device, a silicone elastomer coated fiberoptic bundle

designed to aid in the identification of the esophagus, rectum,

rectosigmoid, and other organs during surgical procedures, be added to

the list of class II, tier 1 devices to be proposed for exemption from

the requirement of premarket notification in a future issue of the

Federal Register.

FDA disagrees with this comment. As stated in the July 21, 1994,

proposal, in early 1994, FDA's Office of Device Evaluation undertook a

risk assessment of all devices in order to ensure the proper allocation

of resources for the review process. Under this risk assessment, all

class I, class II, and class III devices were placed into one of three

tiers based upon the inherent risk associated with each device. Tier 3

devices include all first and second of a kind devices utilizing new

technology or having new intended uses(s), as well as other devices

determined by their inherent risk to require an intensive review. These

tier 3 devices require intensive scientific and labeling review by a

review team as well as advisory panel input. Tier 2 devices include

devices which require routine scientific and labeling review. This tier

encompasses the majority of 510(k)'s and select premarket approval

applications. Tier 1 devices include, among other things, devices which

have a minimal inherent risk and whose review focuses upon intended

use.

FDA had found EIB to be substantially equivalent to both the

gastroenterology-urology fiberoptic retractor (Sec. 876.4530), a class

I device and the class I transilluminator (Sec. 886.1945). However,

upon further consideration, FDA now believes that EIB would have been

more appropriately classified under the fiberoptic light ureteral

catheter (Sec. 876.4020), a class II device, which is also a fiberoptic

bundle that emits light, but is inserted into the ureter to enable it

to be seen during lower abdominal or pelvic surgery. While the specific

indication statement for these two devices are different, their

intended uses are the same and, therefore, the devices are

substantially equivalent. Like the fiberoptic light ureteral catheter,

EIB is used with a high intensity light source, which could produce

heating and potential damage of body tissues. Concerns identified at

the time of classification of the fiberoptic light ureteral catheter

included thermal burns related to the amount of energy transmitted. For

this reason, FDA has placed the fiberoptic light ureteral catheter in

class II, tier 2. Additionally, endoscopes (which could have been

another predicate) and esophageal dilators (which include the

esophageal bougie) are also tier 2 devices. Furthermore, retaining the

EIB device in class II, tier 2 is justified because EIB is a one-of-a-

kind device. FDA has not yet had sufficient experience with this device

to justify a tier 1 premarket review, i.e., a focused labeling review

for intended use/indications for use. For the reasons stated above, the

EIB device will remain a class II, tier 2 device.

B. Comments Requesting FDA to Expand the Exemption from the Requirement

of Premarket Notification to Include an Additional 56 Devices

4. A total of eight comments requested that the 56 devices listed

in Table 4 also be exempted from the requirement of premarket

notification.

Table 4

------------------------------------------------------------------------

21 CFR Device

------------------------------------------------------------------------

862.2230........................... Chromatographic separation material

for clinical use.

862.2250........................... Gas liquid chromatography system

for clinical use.

866.2600........................... Wood's fluorescent lamp.

868.1930........................... Stethoscope head.

872.3310........................... Coating material for resin

fillings.

872.3730........................... Pantograph.

872.3820........................... Root canal filling resin.

872.4200........................... Dental handpiece and accessories.

872.5470........................... Orthodontic plastic bracket.

872.5500........................... Extraoral orthodontic headgear.

872.6050........................... Saliva absorber.

872.6390........................... Dental floss (including devices

made of any inert materials).

872.6770........................... Cartridge syringe.

874.1060........................... Acoustic chamber for audiometric

testing.

874.4140........................... Ear, nose, and throat bur.

874.4175........................... Nasopharyngeal catheter.

874.4770........................... Otoscope.

874.5220........................... Ear, nose, and throat drug

administration device.

874.5800........................... External nasal splint.

876.4890........................... Urological table and accessories

(manually powered).

876.5160........................... Urological clamp for males.

876.5250........................... Urine collector and accessories

(not connected to indwelling

catheter).

878.4040........................... Surgical apparel (except surgical

gowns and masks).

878.4460........................... Surgeon's gloves.

880.5110........................... Hydraulic adjustable hospital bed.

[[Page 38898]]

880.5120........................... Manual adjustable hospital bed.

880.5180........................... Burn sheet.

880.6250........................... Patient examination glove.

880.6280........................... Medical insole.

880.6350........................... Battery-powered medical examination

light.

880.6970........................... Liquid crystal vein locator.

884.5150........................... Nonpowered breast pump.

884.5425........................... Scented or scented deodorized

menstrual pad.

884.5435........................... Unscented menstrual pad.

886.4370........................... Keratome (AC powered).

888.5960........................... Cast removal instrument (AC

powered).

892.1300........................... Nuclear rectilinear scanner.

892.1320........................... Nuclear uptake probe.

892.1330........................... Nuclear whole body scanner.

892.1410........................... Nuclear electrocardiograph

synchronizer.

892.1610........................... Diagnostic x-ray beam limiting

device.

892.1620........................... Cine or spot flourographic x-ray

camera.

892.1760........................... Diagnostic x-ray tube housing

assembly.

892.1770........................... Diagnostic x-ray tube mount.

892.1830........................... Radiographic patient cradle.

892.1850........................... Radiographic film cassette.

892.1860........................... Radiographic film/cassette changer.

892.1880........................... Wall-mounted radiographic cassette

holder.

892.1890........................... Radiographic film illuminator.

892.1910........................... Radiographic grid.

892.1970........................... Radiographic ECG/respirator

synchronizer.

892.1980........................... Radiologic table.

892.5770........................... Powered radiation therapy patient

support assembly.

892.5780........................... Light beam patient position

indicator.

892.5930........................... Therapeutic x-ray tube housing

assembly.

892.6500........................... Personnel protective shield.

------------------------------------------------------------------------

FDA has concluded that 18 of the 56 devices listed in Table 4 are

not candidates for exemption from the requirement of premarket

notification because they are currently classified into class II and/or

class III. These devices are listed in Table 5.

Table 5

------------------------------------------------------------------------

21 CFR Device

------------------------------------------------------------------------

872.3310........................... Coating material for resin

fillings.

872.3820........................... Root canal filling resin.

872.5470........................... Orthodontic plastic bracket.

872.5500........................... Extraoral orthodontic headgear.

872.6770........................... Cartridge syringe.

884.5425........................... Scented or scented deodorized

menstrual pad.

892.1610........................... Diagnostic x-ray beam limiting

device.

892.1620........................... Cine or spot flourographic x-ray

camera.

892.1760........................... Diagnostic x-ray tube housing

assembly.

892.1770........................... Diagnostic x-ray tube mount.

892.1830........................... Radiographic patient cradle.

892.1850........................... Radiographic film cassette.

892.1860........................... Radiographic film/cassette changer.

892.1880........................... Wall-mounted radiographic cassette

holder.

892.1980........................... Radiologic table.

892.5770........................... Powered radiation therapy patient

support assembly.

892.5780........................... Light beam patient position

indicator.

892.5930........................... Therapeutic x-ray housing assembly.

------------------------------------------------------------------------

In accordance with section 513(e)(1) of the act (21 U.S.C.

360c(e)(1)), any interested person may petition FDA to reclassify a

device based on new information respecting such a device and to exempt

such a device from the requirement of premarket notification. The form

and content required for such a petition are set forth in 21 CFR

860.123. The request and reasons supporting the request for exemption

from the requirement of premarket notification should be included in

the supplemental data sheet. If a device is reclassified into class I,

FDA may also exempt the device from the requirement of premarket

notification.

Thirteen of the 56 devices listed in Table 4 have already been

exempted from premarket notification procedures on the dates listed

below. These devices are listed in Table 6.

Table 6

------------------------------------------------------------------------

Federal Register

Date citation 21 CFR Device

------------------------------------------------------------------------

Nov. 9, 1982..... 47 FR 50823...... 866.2600........ Wood's

fluorescent

lamp.

June 12, 1989.... 54 FR 25042...... 868.1930........ Stethoscope

head.

Aug. 12, 1987.... 52 FR 30082...... 872.3730........ Pantograph.

Apr. 5, 1989..... 54 FR 13828...... 872.6050........ Saliva absorber.

Dec. 7, 1994..... 59 FR 63005...... 874.5220........ Ear, nose, and

throat drug

administration

device.

Aug. 25, 1987.... 52 FR 32110...... 874.5800........ External nasal

splint.

June 12, 1989.... 54 FR 25042...... 876.4890........ Urological table

and accessories

(manually

powered).

June 12, 1989.... 54 FR 25042...... 880.5110........ Hydraulic

adjustable

hospital bed.

June 12, 1989.... 54 FR 25042...... 880.5120........ Manual

adjustable

hospital bed.

Dec. 7, 1994..... 59 FR 63005...... 880.5180........ Burn sheet.

June 12, 1989.... 54 FR 25042...... 880.6280........ Medical insole.

Oct. 21, 1980.... 45 FR 69682...... 880.6350........ Battery-powered

medical

examination

light.

June 12, 1989.... 54 FR 25042...... 880.6970........ Liquid crystal

vein locator.

------------------------------------------------------------------------

Ten of the 56 devices listed in Table 4 are candidates for

exemption from the requirement of premarket notification. These

devices, which are listed in Table 7, along with the flotation cushion

(Sec. 890.3175) and the traction accessory (Sec. 890.5925), are being

proposed for premarket notification exemption elsewhere in today's

issue of the Federal Register.

Table 7

------------------------------------------------------------------------

21 CFR Device

------------------------------------------------------------------------

862.2230........................... Chromatographic separation material

for clinical use.

872.2230........................... Dental floss (including devices

made of inert materials).

874.1060........................... Acoustic chamber for audiometric

testing.

874.4140........................... Ear, nose, and throat bur.

874.4175........................... Nasopharyngeal catheter.

[[Page 38899]]

874.4770........................... Otoscope.

884.5150........................... Nonpowered breast pump.

884.5435........................... Unscented menstrual pad.

888.5960........................... Cast removal instrument (AC

powered).

892.6500........................... Personnel protective shield.

------------------------------------------------------------------------

For fifteen of the 56 devices listed in Table 8, FDA has concluded

that these devices are not candidates for exemption from premarket

notification procedures because they do not meet the criteria for

exemption which is set out below.

Table 8

------------------------------------------------------------------------

21 CFR Device

------------------------------------------------------------------------

862.2250........................... Gas liquid chromatography system

for clinical use.

872.4200........................... Dental handpiece and accessories.

876.5160........................... Urological clamp for males.

876.5250........................... Urine collector and accessories

(not connected to indwelling

catheter).

878.4040........................... Surgical apparel (except surgical

gowns and masks).

878.4460........................... Surgeon's gloves.

880.6250........................... Patient examination glove.

886.4370........................... Keratome (AC powered).

892.1300........................... Nuclear rectilinear scanner.

892.1320........................... Nuclear uptake probe.

892.1330........................... Nuclear whole body scanner.

892.1410........................... Nuclear electrocardiograph

synchronizer.

892.1890........................... Radiographic film illuminator.

892.1910........................... Radiographic grid.

892.1970........................... Radiographic ECG/respirator

synchronizer.

------------------------------------------------------------------------

As stated in the preamble of July 21, 1994, proposal, in order for

devices to be exempted from the requirement of premarket notification,

they must meet all of the following criteria: (1) The device does not

have a significant history of false or misleading claims; (2) the

device does not have a significant history of risk; (3) characteristics

of the device necessary for its safe and effective performance are well

established; (4) anticipated changes in the device that could affect

safety and effectiveness will either: (a) be readily detectable by

users by visual examination or other means or (b) not materially

increase the risk of injury, incorrect diagnosis, or ineffective

treatment; and (5) any changes in the device would not be likely to

result in a change in the device's classification.

The gas liquid chromatography system for clinical use

(Sec. 862.2250); the urological clamp for males (Sec. 876.5160); and

the urine collector and accessories (Sec. 876.5250) are class I, tier 2

devices. As stated above, tier 2 devices require review of performance

data because characteristics of these devices necessary for their safe

and effective performance are not well established.

Characteristics of the dental handpiece and accessories

(Sec. 872.4200) and the nuclear rectilinear scanner (Sec. 892.1300),

which are necessary for their safety and effective performance, are not

well established. Moreover, anticipated changes in the devices that

could affect safety and effectiveness are not readily detectable

visually or by routine testing and could materially increase the risk

of injury, incorrect diagnosis, or ineffective treatment.

The keratome (Sec. 886.4370) is not a candidate for exemption from

premarket notification because anticipated changes that could affect

the safety and effectiveness of the device are not readily detectable

visually or by routine testing.

Surgical apparel (except surgical gowns and masks (Sec. 878.4040))

and surgeons's gloves (Sec. 878.4460) are not candidates for exemption

from premarket notification procedures because anticipated changes that

could affect safety and effectiveness are not readily detectable

visually or by routine testing and could materially increase the risk

of injury, namely the transmission of blood bourne pathogens.

In the Federal Register of January 13, 1989 (53 FR 1604), the

exemptions from premarket notification and current good manufacturing

practices for patient examination gloves (Sec. 880.6250) were revoked

because of the importance of this device in preventing the transmission

between patients and health care workers of human immunodeficiency

virus (HIV) that causes acquired immune deficiency syndrome (AIDS).

The nuclear uptake probe (Sec. 892.1320); the nuclear

electrocardiograph synchronizer (Sec. 892.1410); the nuclear whole body

scanner (Sec. 892.1330); the radiographic film illuminator

(Sec. 892.1890); the radiographic grid (Sec. 892.1910); and the

radiographic ECG/respirator synchronizer (Sec. 892.1970) are not

candidates for exemption from the requirement of premarket notification

because anticipated changes that could affect the devices' safety and

effectiveness are not readily detectable visually or by routine testing

and could materially increase the risk of injury, incorrect diagnosis,

or ineffective treatment.

III. Environmental Impact

The agency has determined under 21 CFR 25.24(e)(2) 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.

IV. Analysis of Impact

FDA has examined the impacts of the final rule under Executive

Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).

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, the final

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 final rule reduces a regulatory burden

by exempting manufacturers of devices subject to the final rule from

the requirement of premarket notification, the agency certifies that

the final rule will not have a significant economic impact on a

substantial number of small entities. Therefore, under the Regulatory

Flexibility Act, no further analysis is required.

List of Subjects in 21 CFR Parts 862 and 872

Medical devices.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under

authority delegated to the Commissioner of Food and Drugs, 21 CFR parts

862 and 872 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: Secs. 501, 510, 513, 515, 520, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,

371).

2. Section 862.2310 is amended by revising paragraph (b) to read as

follows:

Sec. 862.2310 Clinical sample concentrator.

* * * * *

[[Page 38900]]

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

3. Section 862.2320 is amended by revising paragraph (b) to read as

follows:

Sec. 862.2320 Beta or gamma counter for clinical use.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

4. Section 862.2485 is amended by revising paragraph (b) to read as

follows:

Sec. 862.2485 Electrophoresis apparatus for clinical use.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

5. Section 862.2720 is amended by revising paragraph (b) to read as

follows:

Sec. 862.2720 Plasma oncometer for clinical use.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

6. Section 862.2800 is amended by revising paragraph (b) to read as

follows:

Sec. 862.2800 Refractometer for clinical use.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

7. Section 862.2920 is amended by revising paragraph (b) to read as

follows:

Sec. 862.2920 Plasma viscometer for clinical use.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

PART 872--DENTAL DEVICES

8. The authority citation for 21 CFR part 872 continues to read as

follows:

Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,

371).

9. Section 872.3740 is amended by revising paragraph (b) to read as

follows:

Sec. 872.3740 Retentive and splinting pin.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

10. Section 872.3810 is amended by revising paragraph (b) to read

as follows:

Sec. 872.3810 Root canal post.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

11. Section 872.6100 is amended by revising paragraph (b) to read

as follows:

Sec. 872.6100 Anesthetic warmer.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

Dated: July 18, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95-18458 Filed 7-27-95; 8:45 am]

BILLING CODE 4160-01-F