Medical Devices; Exemptions From Premarket Notification; Class II Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 862 and 892

[Docket Nos. 98P-0506 and 98P-0621]

Medical Devices; Exemptions From Premarket Notification; Class II

Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is publishing an order

granting petitions requesting exemption from the premarket notification

requirements for certain class II devices. FDA is publishing this order

in accordance with procedures established by the Food and Drug

Administration Modernization Act of 1997 (FDAMA).

EFFECTIVE DATE: January 8, 1999.

FOR FURTHER INFORMATION CONTACT: Heather S. Rosecrans, Center for

Devices and Radiological Health (HFZ-404), Food and Drug

Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-

1190.

SUPPLEMENTARY INFORMATION:

I. Statutory Background

Under section 513 of the Federal Food, Drug, and Cosmetic Act (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

Medical Device Amendments of 1976 (the 1976 amendments (Pub. L. 94-

295)), as amended by the Safe Medical Devices Act of 1990 (the SMDA

(Pub. L. 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 assure 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, 21 CFR part

[[Page 1124]]

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.

On November 21, 1997, the President signed into law FDAMA (Pub. L.

105-115). Section 206 of FDAMA, in part, added a new section 510(m) to

the act. Section 510(m)(1) of the act requires FDA, within 60 days

after enactment of FDAMA, to publish in the Federal Register a list of

each type of class II device that does not require a report under

section 510(k) of the act to provide reasonable assurance of safety and

effectiveness. Section 510(m) of the act further provides that a 510(k)

will no longer be required for these devices upon the date of

publication of the list in the Federal Register. FDA published that

list in the Federal Register of January 21, 1998 (63 FR 3142).

Section 510(m)(2) of the act provides that, 1 day after date of

publication of the list under section 510(m)(1), FDA may exempt a

device on its own initiative or upon petition of an interested person,

if FDA determines that a 510(k) is not necessary to provide reasonable

assurance of the safety and effectiveness of the device. This section

requires FDA to publish in the Federal Register a notice of intent to

exempt a device, or of the petition, and to provide a 30-day comment

period. Within 120 days of publication of this document, FDA must

publish in the Federal Register its final determination regarding the

exemption of the device that was the subject of the notice. If FDA

fails to respond to a petition under this section within 180 days of

receiving it, the petition shall be deemed granted.

II. Criteria for Exemption

There are a number of factors FDA may consider to determine whether

a 510(k) is necessary to provide reasonable assurance of the safety and

effectiveness of a class II device. These factors are discussed in the

guidance the agency issued on February 19, 1998, entitled ``Procedures

for Class II Device Exemptions from Premarket Notification, Guidance

for Industry and CDRH Staff.'' That guidance can be obtained through

the World Wide Web on the CDRH home page at ``http://www.fda.gov/cdrh''

or by facsimile through CDRH Facts-on-Demand at 1-800-899-0381 or 301-

827-0111. Specify ``159'' when prompted for the document shelf number.

III. Petitions

FDA has received the following petitions requesting an exemption

from premarket notification for class II devices:

1. Abbott Laboratories, 21 CFR 862.1715, triiodothyronin uptake

test system devices.

2. Radiological Imaging Technology, 21 CFR 892.5050, film dosimetry

system, a.k.a. film scanning system.

In the Federal Register of September 30, 1998 (63 FR 52275), FDA

published a notice announcing that these petitions had been received

and providing an opportunity for interested persons to submit comments

on the petitions by October 30, 1998. FDA received no comments. FDA has

reviewed these petitions and has determined that these devices meet the

criteria for exemption described previously and is, therefore, issuing

this order exempting these devices from the requirements of premarket

notification and is codifying this order in the Code of Federal

Regulations (CFR). The film dosimetry system is an accessory to the

medical charged-particle radiation therapy system classified in 21 CFR

892.5050. The exemption for the film dosimetry system is limited only

to film dosimetry systems intended for use as a quality control system.

(See 21 CFR 892.9 for further information on limitations on exemptions

for radiological devices.)

IV. 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.

V. Analysis of Impacts

FDA has examined the impacts of the final 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 (Pub. L. 104-121) and the Unfunded Mandates Reform Act of 1995

(Pub. L. 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, 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.

If a rule has a significant economic impact on a substantial number

of small entities, 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 will relieve a burden

and simplify the marketing of these devices, 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.

VI. Paperwork Reduction Act of 1995

FDA concludes that 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 Part 862

Medical devices.

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 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 862.1715 is amended by revising paragraph (b) to read as

follows:

Sec. 862.1715 Triiodothyronine uptake test system.

* * * * *

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

premarket notification procedures in subpart E of part 807 of this

chapter subject to the limitations in Sec. 862.9.

PART 892--RADIOLOGY DEVICES

3. The authority citation for 21 CFR part 892 continues to read as

follows:

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

4. Section 892.5050 is amended by revising paragraph (b) to read as

follows:

[[Page 1125]]

Sec. 892.5050 Medical charged-particle radiation therapy system.

* * * * *

(b) Classification. Class II. When intended for use as a quality

control system, the film dosimetry system (film scanning system)

included as an accessory to the device described in paragraph (a) of

this section, is exempt from the premarket notification procedures in

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

Sec. 892.9.

Dated: December 22, 1998.

D.B. Burlington,

Director, Center for Devices and Radiological Health.

[FR Doc. 99-380 Filed 1-7-99; 8:45 am]

BILLING CODE 4160-01-F