[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