Medical Devices; Retention in Class III and Effective Date of Requirement for Premarket Approval for Three Preamendment Class III Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 874 and 882

[Docket No. 98N-0405]

Medical Devices; Retention in Class III and Effective Date of

Requirement for Premarket Approval for Three Preamendment Class III

Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule

to retain in class III, three preamendment medical devices and to

require the filing of a premarket approval application (PMA) or a

notice of completion of product development protocol (PDP) for the

suction antichoke device, the tongs antichoke device, and the implanted

neuromuscular stimulator. The agency has summarized its findings

regarding the degree of risk of illness or injury designed to be

eliminated or reduced by requiring the devices to meet the statute's

approval requirements and the benefits to the public from the use of

the devices. This action is being taken under the Federal Food, Drug,

and Cosmetic Act (the act) as amended by the Medical Device Amendments

of 1976 (the amendments), the Safe Medical Devices Act of 1990 (the

SMDA), and the Food and Drug Administration Modernization Act of 1997

(FDAMA).

EFFECTIVE DATE: April 14, 1999.

FOR FURTHER INFORMATION CONTACT: Janet L. Scudiero, Center for Devices

and Radiological Health (HFZ-410), Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850, 301-594-1184.

SUPPLEMENTARY INFORMATION:

I. Background

The SMDA (Pub. L. 101-629) added new section 515(i) (21 U.S.C.

360e(i)) to the act. This section requires FDA to review the

classification of preamendments class III devices for which no final

rule has been issued requiring the submission of PMA's and

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to determine whether each device should be reclassified into class I or

class II or remain in class III. For devices remaining in class III,

SMDA directed FDA to develop a schedule for issuing regulations to

require premarket approval.

In the Federal Register of May 6, 1994 (59 FR 23731), FDA issued a

notice of availability of a preamendments class III devices strategy

document. The strategy document set forth FDA's plans for implementing

the provisions of section 515(i) of the act for preamendments class III

devices for which FDA had not yet required premarket approval. FDA

divided this universe of devices into three groups as referenced in the

May 6, 1994, notice.

In the Federal Register of July 30, 1998 (63 FR 40673), FDA

published a proposed rule (hereinafter referred to as the July 1998

proposed rule), to retain in class III, the suction antichoke device

(Sec. 874.5350 (21 CFR 874.5350)), the tongs antichoke device

(Sec. 874.5370 (21 CFR 874.5370)), and the implanted neuromuscular

stimulator device (Sec. 882.5860 (21 CFR 882.5860)), and to require the

filing of a PMA or PDP for these three preamendment class III devices.

In accordance with section 515(b)(2)(A) of the act, FDA included in the

preamble to the July 1998 proposed rule the agency's findings with

respect to the degree of risk of illness or injury designed to be

eliminated or reduced by requiring these devices to have an approved

PMA or a declared PDP and the benefit to the public from use of the

device.

The preamble to the July 1998 proposed rule also provided an

opportunity for interested persons to submit comments on the proposed

rule and the agency's findings, and under section 515(b)(2)(B) of the

act, FDA provided an opportunity for interested persons to request a

change in the classification of the device based on new information

relevant to its classification. Any petition requesting a change in the

classification of the devices was required to be submitted by August

13, 1998. The comment period closed October 28, 1998. The agency did

not receive any comments or petitions requesting a change in the

classification of these devices.

II. Findings With Respect to Risks and Benefits

Under section 515(b)(3) of the act, FDA is adopting the findings as

published in the July 1998 proposed rule. As required by section by

section 515(b)(2)(A) of the act, FDA published its findings regarding:

(1) The degree of risk of illness or injury designed to be eliminated

or reduced by requiring that these devices have an approved PMA or a

declared completed PDP; and (2) the benefits to the public from the use

of the device.

These findings are based on the reports and recommendations of the

advisory committees (the panels) for these devices, the Ear Nose and

Throat Devices Panel and the Neurological Devices Panel, for the

classification of the devices along with any additional information FDA

discovered. Additional information can be found in the proposed and

final rules classifying these devices in the Federal Register of

January 22, 1982 (47 FR 3280) and November 6, 1986 (51 FR 40378) for

the ear, nose and throat devices; and of November 28, 1978 (43 FR

55640) and September 4, 1979 (44 FR 51726) for the neurological device,

respectively.

III. Final Rule

Under section 515(b)(3) of the act, FDA is adopting the findings as

published in the preamble to the July 30, 1998, proposed rule and

issuing this final rule to require premarket approval of the generic

type of devices by revising Secs. 874.5350(c), 874.5370(c), and

882.5860(c).

Under the final rule, a PMA or a notice of completion of a PDP is

required to be filed on or before July 13, 1999, for any of these class

III preamendment devices that were in commercial distribution before

May 28, 1976, or that have been found by FDA to be substantially

equivalent to such a device on or before July 13, 1999. An approved PMA

or a declared completed PDP is required to be in effect for any such

devices on or before 180 days after FDA files the application. Any

other class III preamendment device subject to this rule that was not

in commercial distribution before May 28, 1976, is required to have an

approved PMA or a declared completed PDP in effect before it may be

marketed.

If a PMA or a notice of completion of a PDP for any of these class

III preamendment devices is not filed on or before the 90th day past

the effective date of this regulation, that device will be deemed

adulterated under section 501(f)(1)(A) of the act (21 U.S.C.

351(f)(1)(A)), and commercial distribution of the device will be

required to cease immediately. The device may, however, be distributed

for investigational use, if the requirements of the investigational

device exemption (IDE) regulations (part 812 (21 CFR part 812)) are

met.

Under Sec. 812.2(d) of the IDE regulations, FDA hereby stipulates

that the exemptions from the IDE requirements in Sec. 812.2(c)(1) and

(c)(2) will no longer apply to clinical investigations of these class

III preamendment devices. Further, FDA concludes that investigational

class III preamendment devices are significant risk devices as defined

in Sec. 812.3(m) and advises that, as of the effective date of

Secs. 874.5350(c), 874.5370(c), and 882.5860(c), the requirements of

the IDE regulations regarding significant risk devices will apply to

any clinical investigation of these class III preamendment devices. For

any of these class III preamendment devices that is not subject to a

timely filed PMA or PDP, an IDE must be in effect under Sec. 812.20 on

or before 90 days after the effective date of this regulation or

distribution of the device must cease. FDA advises all persons

presently sponsoring a clinical investigation involving any of these

class III preamendment devices to submit an IDE application to FDA no

later than 60 days after the effective date of this final rule to avoid

the interruption of ongoing investigations.

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

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options that would minimize any significant impact of a rule on small

entities. Because FDA believes that there is little or no interest in

marketing these devices, the agency certifies that the final rule, will

not have a significant 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 does not contain information

collection provisions. Therefore, clearance by the Office of Management

and Budget under the Paperwork Reduction Act of 1995 is not required.

List of Subjects in 21 CFR Parts 874 and 882

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

874 and 882 are amended as follows:

PART 874--EAR, NOSE, AND THROAT DEVICES

1. The authority citation for 21 CFR part 874 continues to read as

follows:

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

2. Section 874.5350 is amended by revising paragraph (c) to read as

follows:

Sec. 874.5350 Suction antichoke device.

* * * * *

(c) Date PMA or notice of completion of PDP is required. A PMA or a

notice of completion of a PDP for a device is required to be filed with

the Food and Drug Administration on or before July 13, 1999 for any

suction antichoke device that was in commercial distribution before May

28, 1976, or that has, on or before July 13, 1999, been found to be

substantially equivalent to a suction antichoke device that was in

commercial distribution before May 28, 1976. Any other suction

antichoke device shall have an approved PMA or declared completed PDP

in effect before being placed in commercial distribution.

3. Section 874.5370 is amended by revising paragraph (c) to read as

follows:

Sec. 874.5370 Tongs antichoke device.

* * * * *

(c) Date PMA or notice of completion of PDP is required. A PMA or a

notice of completion of a PDP for a device is required to be filed with

the Food and Drug Administration on or before July 13, 1999 for any

tongs antichoke device that was in commercial distribution before May

28, 1976, or that has, on or before July 13, 1999, been found to be

substantially equivalent to a tongs antichoke device that was in

commercial distribution before May 28, 1976. Any other tongs antichoke

device shall have an approved PMA or declared completed PDP in effect

before being placed in commercial distribution.

PART 882--NEUROLOGICAL DEVICES

4. The authority citation for 21 CFR part 882 continues to read as

follows:

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

5. Section 882.5860 is amended by revising paragraph (c) to read as

follows:

Sec. 882.5860 Implanted neuromuscular stimulator.

* * * * *

(c) Date PMA or notice of completion of PDP is required. A PMA or

notice of completion of a PDP for a device described in paragraph (b)

of this section is required to be filed with the Food and Drug

Administration on or before July 13, 1999 for any implanted

neuromuscular stimulator that was in commercial distribution before May

28, 1976, or that has, on or before July 13, 1999, been found to be

substantially equivalent to an implanted neuromuscular stimulator that

was in commercial distribution before May 28, 1976. Any other implanted

neuromuscular stimulator shall have an approved PMA or declared

completed PDP in effect before being placed in commercial distribution.

Dated: April 7, 1999.

William K. Hubbard,

Acting Deputy Commissioner for Policy.

[FR Doc. 99-9221 Filed 4-13-99; 8:45 am]

BILLING CODE 4160-01-F