[Federal Register Volume 63, Number 159 (Tuesday, August 18, 1998)]
[Proposed Rules]
[Pages 44177-44181]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-21999]


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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 Class III Preamendments Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; opportunity to request a change in 
classification.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to require 
the filing of a premarket approval application (PMA) or a notice of 
completion of a product development protocol (PDP) for the following 
three class III preamendments devices: Lung water monitor, powered 
vaginal muscle stimulator for therapeutic use, and stair-climbing 
wheelchair. The agency also is summarizing its proposed 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. In addition, FDA is announcing the opportunity for 
interested persons to request that the agency change the classification 
of any of the devices based on new information. This action implements 
certain statutory requirements.

DATES: Written comments by November 16, 1998; request for a change in 
classification by September 2, 1998. FDA intends that, if a final rule 
based on this proposed rule is issued, PMA's will be required to be 
submitted within 90 days of the effective date of the final rule.

ADDRESSES: Submit written comments or requests for a change in 
classification to the Dockets Management Branch (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

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--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the act), as amended by 
the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 
94-295) and the Safe Medical Devices Act of 1990 (the SMDA) (Pub. L. 
101-629), established a comprehensive system for the regulation of 
medical devices intended for human use. Section 513 of the act (21 
U.S.C. 360c) established three categories (classes) of devices, 
depending on the regulatory controls needed to provide reasonable 
assurance of their safety and effectiveness. The three categories of 
devices are class I (general controls), class II (special controls), 
and class III (premarket approval).
    Under section 513 of the act, devices that were in commercial 
distribution before May 28, 1976 (the date of enactment of the 1976 
amendments), generally referred to as preamendments devices, are 
classified after FDA has: (1) Received a recommendation from a device 
classification panel (an FDA advisory committee); (2) published the 
panel's recommendation for comment, along with a proposed regulation 
classifying the device; and (3) published a final regulation 
classifying the device. FDA has classified most preamendments devices 
under these procedures.
    Devices that were not in commercial distribution prior to May 28, 
1976, generally referred to as postamendments devices, are classified 
automatically by statute (section 513(f) of the act) into class III 
without any FDA rulemaking process. Those devices remain in class III 
and require premarket approval, unless and until the device is 
reclassified into class I or II or FDA issues an order finding the 
device to be substantially equivalent, in accordance with section 
513(i) of the act, to a predicate device that does not require 
premarket approval. The agency determines whether new devices are 
substantially equivalent to previously offered devices by means of 
premarket notification procedures in section 510(k) of the act (21 
U.S.C. 360(k)) and 21 CFR part 807.
    Section 515(b)(1) of the act (21 U.S.C. 360e(b)(1)) established the 
requirement that a preamendments device that FDA has classified into 
class III is subject to premarket approval. A preamendments class III 
device may be commercially distributed without an approved PMA or a 
notice of completion of a PDP until 90 days after FDA issues a final 
rule requiring premarket approval for the device, or 30 months after 
final classification of the device under section 513 of the act, 
whichever is later. Also, a preamendments device subject to the 
rulemaking procedure under section 515(b) of the act is not required to 
have an approved investigational device exemption (IDE) (see 21 CFR 
part 812) contemporaneous with its interstate distribution until the 
date identified by FDA in the final rule requiring the submission of a 
PMA for the device. At that time, an IDE is required only if a PMA has 
not been submitted or a PDP completed.
    Section 515(b)(2)(A) of the act provides a proceeding to issue a 
final rule to require premarket approval shall be initiated by 
publication of a notice of proposed rulemaking containing: (1) The 
regulation; (2) proposed findings with respect to the degree of risk of 
illness or injury designed to be eliminated or reduced by requiring the 
device to have an approved PMA or a declared completed PDP and the 
benefit to the public from the use of the device; (3) an opportunity 
for the submission of comments on the proposed rule and the proposed 
findings; and (4) an opportunity to request a change in the 
classification of the device based on new information relevant to the 
classification of the device.
    Section 515(b)(2)(B) of the act provides that if FDA receives a 
request for a change in the classification of the device within 15 days 
of the publication of the notice, FDA shall, within 60 days of the 
publication of the notice, consult with the appropriate FDA advisory 
committee and publish a notice denying the request for change in 
reclassification or announcing its intent to initiate a proceeding to 
reclassify the device under section 513(e) of the act. Section 
515(b)(3) of the act provides that FDA shall, after the close of the 
comment period on the proposed rule and consideration of any comments 
received, issue a final rule to require premarket approval, or publish 
a notice terminating the proceeding together with the reasons for such 
termination. If FDA terminates the proceeding, FDA is required to 
initiate reclassification of the device under section 513(e) of the 
act, unless the reason for termination is that the device is a banned 
device under section 516 of the act (21 U.S.C. 360f).
    If a proposed rule to require premarket approval for a 
preamendments device is finalized, section 501(f)(2)(B) of the act (21 
U.S.C.

[[Page 44178]]

351(f)(2)(B)) requires that a PMA or notice of completion of a PDP for 
any such device be filed within 90 days of the date of issuance of the 
final rule or 30 months after the final classification of the device 
under section 513 of the act, whichever is later. If a PMA or notice of 
completion of a PDP is not filed by the later of the two dates, 
commercial distribution of the device is required to cease. The device 
may, however, be distributed for investigational use if the 
manufacturer, importer, or other sponsor of the device complies with 
the IDE regulations. If a PMA or notice of completion of a PDP is not 
filed by the later of the two dates, and no IDE is in effect, the 
device is deemed to be adulterated within the meaning of section 
501(f)(1)(A) of the act, and subject to seizure and condemnation under 
section 304 of the act (21 U.S.C. 334) if its distribution continues. 
Shipment of devices in interstate commerce will be subject to 
injunction under section 302 of the act (21 U.S.C. 332), and the 
individuals responsible for such shipment will be subject to 
prosecution under section 303 of the act (21 U.S.C. 333). In the past, 
FDA has requested that manufacturers take action to prevent the further 
use of devices for which no PMA has been filed and may determine that 
such a request is appropriate for the class III devices that are the 
subjects of this regulation.
    The act does not permit an extension of the 90-day period after 
issuance of a final rule within which an application or a notice is 
required to be filed. The House Report on the 1976 amendments states 
that:
     [t]he thirty month `grace period' afforded after classification 
of a device into class III * * * is sufficient time for 
manufacturers and importers to develop the data and conduct the 
investigations necessary to support an application for premarket 
approval
 (H. Rept. 94-853, 94th Cong., 2d sess. 42 (1976)).
    The SMDA added section 515(i) to the act requiring 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 to 
determine whether or not 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. The SMDA does not, however, prevent FDA 
from proceeding immediately to rulemaking under section 515(b) of the 
act on specific devices, in the interest of public health, independent 
of the procedures of section 515(i). Indeed, proceeding directly to 
rulemaking under section 515(b) of the act is consistent with Congress' 
objective in enacting section 515(i), i.e., that preamendments class 
III devices for which PMA's have not been required either be 
reclassified to class I or class II or be subject to the requirements 
of premarket approval. Moreover, in this proposal, interested persons 
are being offered the opportunity to request reclassification of any of 
the devices.
    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 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.
    Group 1 devices are devices that FDA believes raise significant 
questions of safety and/or effectiveness but are no longer used or are 
in very limited use. FDA's strategy is to call for PMA's for all Group 
1 devices in an omnibus section 515(b) of the act rulemaking action. In 
the Federal Register of September 7, 1995 (60 FR 46718), FDA 
implemented this strategy by proposing requiring the filing of a PMA or 
a notice of completion of a PDP for 43 class III preamendments devices. 
Subsequently, in the Federal Register of September 27, 1996 (61 FR 
50704), FDA called for the filing of a PMA or a notice of completion of 
a PDP for 41 preamendments class III devices. (Due to public comment, 
the agency is reconsidering its position on the two remaining devices 
subject to the September 7, 1995 proposal).
    Group 2 devices are devices that FDA believes have a high potential 
for being reclassified into class II. In the Federal Register of August 
14, 1995 (60 FR 41986), and of June 13, 1997 (62 FR 32355), FDA issued 
an order under section 515(i) of the act requiring manufacturers to 
submit safety and effectiveness information on these Group 2 devices so 
that FDA can make a determination as to whether the devices should be 
reclassified.
    Group 3 devices are devices that FDA believes are currently in 
commercial distribution and are not likely candidates for 
reclassification. FDA intends to issue proposed rules to require the 
submission of PMA's for the 15 high priority devices in this group in 
accordance with the schedule set forth in the strategy document. In the 
Federal Register of August 14, 1995 (60 FR 41984), and of June 13, 1997 
(62 FR 32352), FDA issued an order under section 515(i) of the act for 
the 27 remaining Group 3 devices requiring manufacturers to submit 
safety and effectiveness information so that FDA can make a 
determination as to whether the devices should be reclassified or 
retained in class III.
    In the Federal Register of June 18, 1997 (62 FR 33044), FDA 
published a proposed rule to retain the following three devices in 
class III: Lung water monitor; powered vaginal muscle stimulator for 
therapeutic use; and stair-climbing wheelchair. Interested persons were 
given until September 16, 1997, to comment on the proposed rule. During 
the comment period, the agency received no comments on the proposed 
rule. FDA has, therefore, concluded that insufficient information 
exists to establish special controls to provide reasonable assurance of 
the safety and effectiveness of these devices and/or that these devices 
present a potential unreasonable risk of illness or injury. 
Accordingly, in the Federal Register of June 30, 1998 (63 FR 35516), 
FDA published a final rule to retain these devices in class III.

II. Dates New Requirements Apply

    In accordance with section 515(b) of the act, FDA is proposing to 
require that a PMA or a notice of completion of a PDP be filed with the 
agency for class III devices within 90 days after issuance of any final 
rule based on this proposal. An applicant whose device was legally in 
commercial distribution before May 28, 1976, or whose device has been 
found to be substantially equivalent to such a device, will be 
permitted to continue marketing such class III devices during FDA's 
review of the PMA or notice of completion of the PDP. FDA intends to 
review any PMA for the device within 180 days, and any notice of 
completion of a PDP for the device within 90 days of the date of 
filing. FDA cautions that, under section 515(d)(1)(B)(i) of the act, 
the agency may not enter into an agreement to extend the review period 
for a PMA beyond 180 days unless the agency finds that ``* * * the 
continued availability of the device is necessary for the public 
health.''
    FDA intends that, under Sec. 812.2(d), the preamble to any final 
rule based on this proposal will state that, as of the date on which 
the filing of a PMA or a notice of completion of a PDP is required to 
be filed, the exemptions in Sec. 812.2(c)(1) and (c)(2) from the 
requirements of the IDE regulations for preamendments class III devices 
will cease to apply to any device that is: (1) Not legally on the 
market on or before that date, or (2) legally on the market on or 
before that date but for which a PMA

[[Page 44179]]

or notice of completion of a PDP is not filed by that date, or for 
which PMA approval has been denied or withdrawn.
    If a PMA or notice of completion of a PDP for a class III device is 
not filed with FDA within 90 days, after the date of issuance of any 
final rule requiring premarket approval for the device, commercial 
distribution of the device must cease. The device may be distributed 
for investigational use only if the requirements of the IDE regulations 
regarding significant risk devices are met. The requirements for 
significant risk devices include submitting an IDE application to FDA 
for its review and approval. An approved IDE is required to be in 
effect before an investigation of the device may be initiated or 
continued. FDA, therefore, cautions that IDE applications should be 
submitted to FDA at least 30 days before the end of the 90-day period 
after the final rule to avoid interrupting investigations.

III. Proposed Findings With Respect to Risks and Benefits

    As required by section 515(b) of the act, FDA is publishing its 
proposed 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 (panels) for the classification of these devices 
along with any additional information that FDA has discovered. 
Additional information can be found in the following proposed and final 
rules published in the Federal Register on the dates given below, 
classifying these devices: Anesthesiology Devices, 21 CFR part 868 (44 
FR 63292, November 2, 1979, and 47 FR 31130, July 16, 1982); 
Obstetrical and Gynecology Devices, 21 CFR part 884 (44 FR 19894, April 
3, 1979, and 45 FR 12682, February 26, 1980); and Physical Medicine 
Devices, 21 CFR part 890 (44 FR 50458, August 28, 1979, and 48 FR 
53032, November 23, 1983).

IV. Devices Subject to This Proposal

A. Lung Water Monitor (21 CFR 868.2450)

1. Identification
    A lung water monitor is a device used to monitor the trend of fluid 
volume changes in a patient's lung by measuring changes in thoracic 
electrical impedance (resistance to alternating current) by means of 
electrodes placed on a patient's chest.
2. Summary of Data
    The Anesthesiology Device Classification Panel recommended that the 
lung water monitor intended to monitor the trend of fluid volume 
changes in a patient's lung be classified into class III based on the 
panel members personal knowledge of, and experience with, the device 
and the lack of available clinical data. The panel noted that there is 
no acceptable quantitative procedure for measuring changes in lung 
fluid volume. FDA agreed and continues to agree with the panel's 
recommendation that the device be classified into class III.
3. Risks to Health
    a. Incorrect diagnosis: If the device is not calibrated or does not 
accurately measure changes in lung fluid volume, misdiagnosis of the 
patient's condition may result in inappropriate therapy.
    b. Electrical shock: If the device malfunctions or is not properly 
grounded, the patient may receive an electrical shock.
    c. Allergic reaction: The adhesive backing on the electrodes 
applied to the chest may cause skin irritation or an allergic reaction.
    d. Typical risks of catheter placement: Thrombosis and hematoma 
formation may occur.

B. Powered Vaginal Muscle Stimulator for Therapeutic Use (21 CFR 
884.5940)

1. Identification
    A powered vaginal muscle stimulator for therapeutic use is an 
electrically powered device designed to stimulate directly the muscles 
of the vagina with pulsating electrical current. This device is 
intended and labeled for therapeutic use in increasing muscular tone 
and strength in the treatment of sexual dysfunction. This generic type 
of device does not include devices used to treat urinary incontinence.
2. Summary of Data
     The Obstetrical and Gynecological Device Classification Panel 
recommended that the powered vaginal muscle stimulator for therapeutic 
use intended for treatment of sexual dysfunction be classified into 
class III based on their familiarity with the device and the lack of 
information on the effectiveness of the device. FDA agreed and 
continues to agree with the panel's recommendation. The agency noted 
that the device had fallen into disuse and that the published data are 
not adequate to demonstrate the safety and effectiveness of the device.
3. Risks to Health
    a. Burns: Improper voltage control of the device could result in 
electrical burns when the device comes in contact with vaginal tissue.
    b. Electrical shock: Malfunction of the device could result in 
electrical shock to the patient.
    c. Irritation, tissue trauma, hemorrhage, and perforation: Improper 
shape, or other design shortcomings, of the device could cause injury 
to vaginal tissue.
    d. Adverse tissue reaction: Material or substances in the device 
could cause a local tissue or systematic reaction when the device 
contacts the patient.

 C. Stair-Climbing Wheelchair (21 CFR 890.3890)

1. Identification
    A stair-climbing wheelchair is a device with wheels that is 
intended for medical purposes to provide mobility to persons restricted 
to a sitting position. The device is intended to climb stairs by means 
of two endless belt tracks that are lowered from under the chair and 
adjusted to the angle of the stairs.
2. Summary of Data
    The Physical Medicine Device Classification Panel recommended that 
the device intended for medical purposes to provide mobility to persons 
restricted to a sitting position be classified into class III based on 
the potential hazards associated with the device, the panel members 
familiarity with the device, the lack of sufficient data to support the 
safety and effectiveness of the device, and the literature. FDA agreed 
and continues to agree with the panel's recommendation that the device 
be classified into class III.
3. Risks to Health
    The primary risk to health is that of bodily injury. If the device 
fails, the disabled patient could fall and be seriously injured.

V. PMA Requirements

    A PMA for these devices must include the information required by 
section 515(c)(1) of the act. Such a PMA should also include a detailed 
discussion of the risks identified previously, as well as a discussion 
of the effectiveness of the device for which premarket approval is 
sought. In addition, a PMA must include all data and information on: 
(1) Any risks known, or that should be reasonably known, to the 
applicant that have not been identified in this document; (2) the 
effectiveness of the device that is the subject of the

[[Page 44180]]

application; and (3) full reports of all preclinical and clinical 
information from investigations on the safety and effectiveness of the 
device for which premarket approval is sought.
    A PMA should include valid scientific evidence ``obtained from 
well-controlled clinical studies, with detailed data,'' in order to 
provide reasonable assurance of the safety and effectiveness of the 
device for its intended use (see 21 CFR 860.7(c)(2)).
    Applicants should submit any PMA in accordance with FDA's 
``Premarket Approval (PMA) Manual.'' This manual is available upon 
request from FDA, Center for Devices and Radiological Health, Division 
of Small Manufacturers Assistance (HFZ-220), 1350 Piccard Dr., 
Rockville, MD 20850. This manual is also available on the world wide 
web at http://www.fda.gov/cdrh.

VI. PDP Requirements

    A PDP for any of these devices may be submitted in lieu of a PMA, 
and must follow the procedures outlined in section 515(f) of the act. A 
PDP should provide: (1) A description of the device; (2) preclinical 
trial information (if any); (3) clinical trial information (if any); 
(4) a description of the manufacturing and processing of the devices; 
(5) the labeling of the device; and (6) all other relevant information 
about the device. In addition, the PDP must include progress reports 
and records of the trials conducted under the protocol on the safety 
and effectiveness of the device for which the completed PDP is sought. 
Applicants should submit any PDP in accordance with FDA's ``PDP 
Comprehensive Outline with Attachments.'' This outline is available 
upon request from FDA, Center for Devices and Radiological Health, 
Office of Device Evaluation (HFZ-400), 9200 Corporate Blvd., Rockville, 
MD 20850. The outline and other PDP information is also available on 
the world wide web at http://www.fda.gov/cdrh/pdp.

VII. Request for Comments with Data

    Interested persons may, on or before November 16, 1998, submit to 
the Dockets Management Branch (address above) written comments 
regarding this proposal. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.

VIII. Opportunity to Request a Change in Classification

    Before requiring the filing of a PMA or notice of completion of a 
PDP for a device, FDA is required by section 515(b)(2)(A)(i) through 
(b)(2)(A)(iv) of the act and 21 CFR 860.132 to provide an opportunity 
for interested persons to request a change in the classification of the 
device based on new information relevant to the classification. Any 
proceeding to reclassify the device will be under the authority of 
section 513(e) of the act.
    A request for a change in the classification of these devices is to 
be in the form of a reclassification petition containing the 
information required by Sec. 860.123 (21 CFR 860.123), including new 
information relevant to the classification of the device, and shall, 
under section 515(b)(2)(B) of the act, be submitted by September 2, 
1998.
    The agency advises that, to ensure timely filing of any such 
petition, any request should be submitted to the Dockets Management 
Branch (address above) and not to the address provided in 
Sec. 860.123(b)(1). If a timely request for a change in the 
classification of these devices is submitted, the agency will, by 
October 19, 1998, after consultation with the appropriate FDA advisory 
committee and by an order published in the Federal Register, either 
deny the request or give notice of its intent to initiate a change in 
the classification of the device in accordance with section 513(e) of 
the act and 21 CFR 860.130 of the regulations.

IX. 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.

X. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354), 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 proposed rule is consistent with 
the regulatory philosophy and principles identified in the Executive 
Order. In addition, the proposed 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 FDA believes that there is little 
or no interest in marketing these devices, the agency certifies that 
the proposed rule, if issued as a 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.

XI. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed 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 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, it is 
proposed that 21 CFR parts 868, 884, and 890 be 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 PDP is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before (date 90 days after date of 
publication of the final rule in the Federal Register), for any lung 
water monitor that was in commercial distribution before May 28, 1976, 
or that has, on or before (date 90 days after date of publication of 
the final rule in the Federal Register), been found to be substantially 
equivalent to

[[Page 44181]]

a lung water monitor that was in commercial distribution before May 28, 
1976. Any other lung water monitor 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 PDP is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before (date 90 days after date of 
publication of the final rule in the Federal Register), for any powered 
vaginal muscle stimulator for therapeutic use that was in commercial 
distribution before May 28, 1976, or that has, on or before (date 90 
days after date of publication of the final rule in the Federal 
Register), been found to be substantially equivalent to any powered 
vaginal muscle stimulator for therapeutic use 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 PDP is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before (date 90 days after date of 
publication of the final rule in the Federal Register), for any stair-
climbing wheelchair that was in commercial distribution before May 28, 
1976, or that has, on or before (date 90 days after date of publication 
of the final rule in the Federal Register), been found to be 
substantially equivalent to any 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: August 5, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-21999 Filed 8-17-98; 8:45 am]
BILLING CODE 4160-01-F