[Federal Register Volume 65, Number 72 (Thursday, April 13, 2000)]
[Rules and Regulations]
[Pages 19833-19834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-9135]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 868, 884, and 890

[Docket No. 98N-0564]


Medical Devices; 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 three class III preamendment devices in class III and to 
require the filing of a premarket approval application (PMA) or a 
notice of completion of a product development protocol (PDP) for the 
following devices: The lung water monitor, the powered vaginal muscle 
stimulator, and the stair-climbing wheelchair. 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.

DATES: This rule is effective April 13, 2000.

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

    In the Federal Register of August 18, 1998 (63 FR 44177), FDA 
published a proposed rule to require the filing under section 515(b) of 
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(b)), 
of a PMA or a notice of completion of a PDP for three preamendment 
class III devices. In accordance with section 515(b)(A)(2) of the act, 
FDA included in the preamble to the proposal the agency's proposed 
findings with respect to the degree of risk of illness or injury 
designed to be eliminated or reduced by requiring the devices to meet 
the premarket approval requirements of the act, and the benefits to the 
public from use of the devices. The proposed rule also provided an 
opportunity for interested persons to submit comments on the proposed 
rule and the agency's findings. 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. If anyone wanted to submit a petition requesting 
a change in the classification of the three devices, they were required 
to submit it by September 2, 1998. The comment period closed November 
16, 1998.
    FDA received no comments on the proposed rule. FDA received one 
citizen petition requesting a change in the classification of the 
stair-climbing wheelchair from class III to class II. FDA reviewed the 
petition and determined that there was not sufficient information to 
establish special controls to reasonably assure the safety and 
effectiveness of the device. FDA informed the petitioner in a letter 
dated May 10, 1999, that if additional information was submitted under 
section 513(e) of the act (21 U.S.C. 360c(e)) within 30 days to support 
the reclassification of the device, FDA would review the information. 
FDA also stated that if the petitioner did not submit additional 
information within 30 days to show that sufficient information is 
available to establish special controls to reasonably assure the safety 
and effectiveness of the device, FDA would deem the reclassification 
petition withdrawn. FDA has not received any new information from the 
petitioner and has deemed the reclassification petition withdrawn.

II. Findings With Respect to Risks and Benefits

    Under section 515(b)(3) of the act, FDA is adopting the findings it 
published in the proposed rule. As required by section 515(b) 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 devices.
    These findings are based on the reports and recommendations of the 
advisory committees (the panels) for these devices, the Anesthesiology 
and Respiratory Devices Panel, the Obstetrical and Gynecological 
Devices Panel, and the Orthopedic and Rehabilitation Devices Panel for 
the classification of the devices along with any additional information 
that FDA discovered. Additional information can be found in the 
proposed and final rules classifying these devices published in the 
Federal Register of November 2, 1979 (44 FR 63292), and July 16, 1982 
(47 FR 31130), for the lung water monitor; April 3, 1979 (44 FR 19894), 
and February 26, 1980 (45 FR 12682), for the powered vaginal muscle 
stimulator; and August 28, 1979 (44 FR 50458), and November 23, 1983 
(48 FR 53032), for the stair-climbing wheelchair.

III. The Final Rule

    Under section 515(b)(3) of the act, FDA is adopting the findings as 
published in the preamble to the proposed rule and issuing this final 
rule to require premarket approval of these generic types of devices 
for class III preamendment devices by revising parts 868, 884, and 890 
(21 CFR parts 868, 884, and 890).
    Under the final rule, a PMA or a notice of completion of a PDP is 
required to be filed on or before July 12, 2000, 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 12, 2000. 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.

[[Page 19834]]

    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 (21 CFR part 812) are met.

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 (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, 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.
    On August 14, 1996 (60 FR 41984), FDA issued an order under section 
515(i) of the act requiring manufacturers of these three devices (among 
others) to submit information concerning the safety and effectiveness 
of the devices. Manufacturers were required to comply with this order, 
if they wished to market the device. FDA received no submissions in 
response to this order for these three devices. Although one 
manufacturer submitted a reclassification petition for the stair-
climbing wheelchair in response to the proposed rule, the manufacturer 
did not respond to requests for additional information. FDA believes 
that the manufacturer is no longer interested in marketing this device 
because there is limited demand for it. Therefore, 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 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 in 21 CFR Parts 868, 884, and 890

    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 
868, 884, and 890 are amended as follows:

PART 868--ANESTHESIOLOGY DEVICES

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

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

    2. Section 868.2450 is amended by revising paragraph (c) to read as 
follows:


Sec. 868.2450  Lung water monitor.

* * * * *
    (c) Date PMA or notice of completion of a 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 12, 2000, for 
any lung water monitor that was in commercial distribution before May 
28, 1976, or that has, on or before July 12, 2000, been found to be 
substantially equivalent to a lung water monitor that was in commercial 
distribution before May 28, 1976. Any other lung water monitor device 
shall have an approved PMA or declared completed PDP in effect before 
being placed in commercial distribution.

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

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

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

    4. Section 884.5940 is amended by revising paragraph (c) to read as 
follows:


Sec. 884.5940  Powered vaginal muscle stimulator for therapeutic use.

* * * * *
    (c) Date PMA or notice of completion of a 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 12, 2000, for 
any powered vaginal muscle stimulator for therapeutic use that was in 
commercial distribution before May 28, 1976, or that has, on or before 
July 12, 2000, been found to be substantially equivalent to a powered 
vaginal muscle stimulator that was in commercial distribution before 
May 28, 1976. Any other powered vaginal muscle stimulator for 
therapeutic use shall have an approved PMA or declared completed PDP in 
effect before being placed in commercial distribution.

PART 890--PHYSICAL MEDICINE DEVICES

    5. The authority citation for 21 CFR part 890 continues to read as 
follows:

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

    6. Section 890.3890 is amended by revising paragraph (c) to read as 
follows:


Sec. 890.3890  Stair-climbing wheelchair.

* * * * *
    (c) Date PMA or notice of completion of a 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 12, 2000, for any stair-climbing 
wheelchair that was in commercial distribution before May 28, 1976, or 
that has, on or before July 12, 2000, been found to be substantially 
equivalent to a stair-climbing wheelchair that was in commercial 
distribution before May 28, 1976. Any other stair-climbing wheelchair 
shall have an approved PMA or declared completed PDP in effect before 
being placed in commercial distribution.

    Dated: April 3, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-9135 Filed 4-12-00; 8:45 am]
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