Medical Devices; Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices

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.

-----------------------------------------------------------------------

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