[Federal Register Volume 64, Number 71 (Wednesday, April 14, 1999)]
[Rules and Regulations]
[Pages 18327-18329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-9221]


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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