Federal Register / Vol. 63, No. 146 /Thursday, July 30, 1998 / Proposed Rules 40673

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 874 and 882

[Docket No. 98N–0405]

Medical Devices; Retention in Class III

and Effective Date of Requirement for

Premarket Approval for Three

Preamendments Class III 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

retain in class III, three preamendments

class III medical devices, and is

proposing to require the filing of a

premarket approval application (PMA)

or a notice of completion of a product

development protocol (PDP) for these

devices. FDA believes that the suction

antichoke device, the tongs antichoke

device, and the implanted

neuromuscular stimulator device should

remain in class III because insufficient

information exists to determine that

special controls would provide

reasonable assurance of their safety and

effectiveness, and/or these devices

present a potential unreasonable risk of

illness or injury. The agency 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 the agency

to change the classification of any of the

devices based on new information.

DATES: Written comments by October

28, 1998; request for a change in

classification by August 14, 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: 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

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 part 807

(21 CFR part 807) of the regulations.

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 proposed rule; (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.

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
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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 ‘‘the 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 new section 515(i)

to the act (21 U.S.C. 360e(i)). This

section requires FDA to review the

classification of preamendments class III

devices for which no final rule has been

issued requiring the submission of

PMA’s and 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. 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:

1. 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

515(b) rulemaking action. In the Federal

Register of September 7, 1995 (60 FR

46718), FDA implemented this strategy

by proposing to require 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.

2. 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.

3. 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. This proposed rule

would further implement the strategy by

retaining the three devices in class III

(referred to previously) and requiring

manufacturers of such devices to submit

PMA’s or completed PDP’s for the

devices.

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 § 812.2(d) (21

CFR 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 § 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 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
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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 discovered. Additional information

can be found in the proposed and final

rules published in the Federal Register

classifying these devices: On January 22,

1982 (47 FR 3280), and November 6,

1986 (51 FR 40378), for ear, nose, and

throat devices (part 874 (21 CFR part

874)); and on November 28, 1978 (43 FR

55640), and September 4, 1979 (44 FR

51726), for neurological devices (part

882 (21 CFR part 882)).

IV. Devices Subject to This Proposal

A. Suction antichoke device

(§ 874.5350)

1. Identification

A suction antichoke device is a device

intended to be used in an emergency

situation to remove, by the application

of suction, foreign objects that obstruct

a patient’s airway to prevent

asphyxiation to the patient.

2. Summary of Data

The Ear, Nose, and Throat Devices

Classification Panel (the panel)

recommended that the suction

antichoke device intended to be used in

an emergency situation to remove

foreign objects that obstruct a patient’s

airway to prevent asphyxiation to the

patient be classified into class III based

on an unpublished study that showed

unsuccessful performance of the device.

FDA agreed and continues to agree with

the panel’s recommendation. FDA also

notes that the agency received no 515(i)

submissions of safety and effectiveness

information on the device and that

although there was one premarket

notification for the device in 1979, the

device appears to have fallen into

disuse. The agency also realizes that the

Heimlich Maneuver is now recognized

as the best way to assist a choking

victim.

3. Risks to Health

Failure of the device to perform as

intended could result in asphyxiation of

the patient. The effectiveness of the

suction feature of this device for the

removal of foreign objects from an

obstructed airway is questionable.

Certain designs of the device have been

shown to be ineffective.

B. Tongs antichoke device (§ 874.5370)

1. Identification

A tongs antichoke device is a device

intended to be used in an emergency

situation to grasp and remove foreign

objects that obstruct a patient’s airway

to prevent asphyxiation to the patient.

This generic type of device includes a

plastic instrument with serrated ends

that is inserted into the airway in a

blind manner to grasp and extract

foreign objects, and a stainless steel

forceps with spoon ends that is inserted

under tactile guidance to grasp and

extract foreign objects from the airway.

2. Summary of data

The Ear, Nose, and Throat Devices

Classification Panel (the panel)

recommended that the tongs antichoke

device intended to remove foreign

objects that obstruct a patient’s airway

to prevent asphyxiation to the patient be

classified into class III based on an

unpublished study that showed that the

device may grasp an anatomical

structure of the body rather than the

obstructing foreign object and that the

foreign object would not be extracted.

FDA agreed and continues to agree with

the panel’s recommendation. FDA also

notes that the agency received no 515(i)

submissions of safety and effectiveness

information on the device, and that the

device appears to have fallen into

disuse. The are no premarket

notification submissions for the device.

The agency also realizes that the

Heimlich Maneuver is now recognized

as the best way to assist a choking

victim.

3. Risks to health

a. Asphyxiation. The use of the

generic type of device on a patient with

a partial obstruction may force the

obstruction further down the airway,

causing complete obstruction.

b. Damage to anatomical structures.

Anatomical structures grasped by the

tongs can be torn or ruptured. (Risk is

associated primarily with plastic tongs

with serrated ends.)

c. Panic. Injured and bleeding

anatomical structures may result in, or

contribute to panic of the patient. (Risk

is associated primarily with plastic

tongs with serrated ends.)

C. Implanted neuromuscular stimulator

(§ 882.5860)

1. Identification

An implanted neuromuscular

stimulator is a device that provides

electrical stimulation to a patient’s

peroneal or femoral nerve to cause

muscles in the leg to contract, thus

improving the gait in a patient with a

paralyzed leg. The stimulator consists of

an implanted receiver with electrodes

that are placed around a patient’s nerve

and an external transmitter for

transmitting the stimulation pulses

across the patient’s skin to the

implanted receiver. The external

transmitter is activated by a switch in

the heel of the patient’s shoe.

2. Summary of data

The Neurology Devices Classification

Panel recommended that the device

intended to be implanted to improve the

gait of a paralyzed patient be classified

into class III. The Orthopedics Devices

Classification Panel recommended that

the device be classified into class II.

Both classification panels based their

recommendations on their personal

knowledge of the device, the potential

hazards associated with the device,

pertinent literature, and their clinical

experience with the device. FDA agreed

and continues to agree with the

recommendation of the Neurology

Devices Classification Panel. The agency

noted that only limited clinical data on

the device was then available. FDA also

notes that there were no 515(i)

submissions of safety and effectiveness

information on the device and that the

device appears to have fallen into

disuse. There are no premarket

notification submissions for the device.

3. Risks to health

a. Tissue toxicity. The materials in the

implanted components of the device

may cause a toxic or an adverse reaction

in the surrounding tissue.

b. Infection. There is an increased risk

of sepsis associated with the

implantation of a foreign object in the

body.

c. Injury to the nerve. The presence of

the electrode or the output current may

injure the peroneal or femoral nerve.

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)
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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

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 wellcontrolled 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

October 28, 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

§ 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 August 14, 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 § 860.123(b)(1). If a timely request for

a change in the classification of these

devices is submitted, the agency will, by

September 28, 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.

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

(5 U.S.C. 601–612), 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 in 21 CFR Parts 874 and

882

Medical devices.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, it is proposed that

21 CFR parts 874 and 882 be amended

as follows:

PART 874—EAR, NOSE, AND THROAT

DEVICES

1. The authority citation for 21 CFR

part 874 continues to read as follows:

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

360j, 371.

2. Section 874.5350 is amended by

revising paragraph (c) to read as follows:

§ 874.5350 Suction antichoke device.

* * * * *

(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 based on this proposed rule) for any

suction antichoke device 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 based on this proposed rule), been

found to be substantially equivalent to

a suction antichoke device that was in

commercial distribution before May 28,

1976. Any other suction antichoke
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device shall have an approved PMA or

declared completed PDP in effect before

being placed in commercial

distribution.

3. Section 874.5370 is amended by

revising paragraph (c) to read as follows:

§ 874.5370 Tongs antichoke device.

* * * * *

(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 based on this proposed rule) for any

tongs antichoke device 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 based on this proposed rule), been

found to be substantially equivalent to

a tongs antichoke device that was in

commercial distribution before May 28,

1976. Any other tongs antichoke device

shall have an approved PMA or

declared completed PDP in effect before

being placed in commercial

distribution.

PART 882—NEUROLOGICAL DEVICES

4. The authority citation for 21 CFR

part 882 continues to read as follows:

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

360j, 371.

5. Section 882.5860 is amended by

revising paragraph (c) to read as follows:

§ 882.5860 Implanted neuromuscular

stimulator.

* * * * *

(c) Date PMA or notice of completion

of PDP is required. A PMA or notice of

completion of a PDP 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 based on this proposed rule) for any

implanted neuromuscular stimulator

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 based on

this proposed rule), been found to be

substantially equivalent to an implanted

neuromuscular stimulator that was in

commercial distribution before May 28,

1976. Any other implanted

neuromuscular stimulator shall have an

approved PMA or declared completed

PDP in effect before being placed in

commercial distribution.

Dated: July 17, 1998.

D.B. Burlington.

Director, Center for Devices and Radiological

Health.

[FR Doc. 98–20311 Filed 7-29-98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 890

[Docket No. 98N–0467]

Medical Devices; Effective Date of

Requirement for Premarket Approval

for Three Class III Preamendments

Physical Medicine 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 product development

protocol (PDP) for the following three

high priority Group 3 preamendments

class III devices: Microwave diathermy

for uses other than treatment of select

medical conditions such as relief of

pain, muscle spasms, and joint

contractures; ultrasonic diathermy for

uses other than treatment of select

medical conditions such as relief of

pain, muscle spasms, and joint

contractures; and ultrasound and

muscle stimulator for uses other than

treatment of select medical conditions

such as relief of pain, muscle spasms,

and joint contractures. The uses of these

three devices do not include use for the

treatment of malignancies. 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 these devices

based on new information.

DATES: Written comments by October

28, 1998; request for a change in

classification by August 14, 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 part 807

of the regulations (21 CFR part 807).