Federal Register / Vol. 63, No. 146 /Thursday, July 30, 1998 / Proposed Rules 40677

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).
40678 Federal Register / Vol. 63, No. 146 /Thursday, July 30, 1998 / Proposed Rules

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 part 812 (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 that 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

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. 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 3 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

(the September 1995 proposal).

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 of these

43 preamendments class III devices.

(Due to public comment, the agency is

reconsidering its position on the two

remaining devices subject to the

September 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
Federal Register / Vol. 63, No. 146 /Thursday, July 30, 1998 / Proposed Rules 40679

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

further implements the strategy for three

high priority Group 3 class III devices.

II. Dates New Requirements Apply

In accordance with 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),

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

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

original reports and recommendations

of the Physical Medicine Device

Classification Panel (the panel), an

advisory committee for the classification

of these devices, along with any

additional information that FDA has

discovered. Additional information can

be found in the proposed and final rules

classifying these devices into class III,

published in the Federal Register of

August 28, 1979 (44 FR 50458), and the

Federal Register of November 23, 1983

(48 FR 53032), respectively.

IV. Devices Subject to This Proposal

A. Microwave Diathermy (21 CFR

890.5275(b))

1. Identification

A microwave diathermy device for

uses other than treatment of select

medical conditions such as relief of

pain, muscle spasms, and joint

contractures, is a device that applies to

the body electromagnetic energy in the

microwave frequency bands of 915

megahertz to 2,450 megahertz and that

is intended for the treatment of medical

conditions by means other than the

generation of deep heat within body

tissues. Use of this device does not

include use for the treatment of

malignancies.

2. Summary of Data

The panel recommended that the

device intended for applying

therapeutic deep heat be classified into

class II based on the potential hazards

associated with use of the device, on the

panel members’ knowledge of and

clinical experience with the device, and

pertinent literature. FDA agreed with

this recommendation for the above

intended use. FDA also was aware that

the device was being used for additional

purposes for which it had not been

shown to be safe and effective.

Accordingly, FDA believed the device

should also be classified with respect to

all other intended uses. For all other

intended uses other than applying deep

therapeutic heat for treatment of select

medical conditions, the agency still

believes that this device presents a

potential unreasonable risk of injury

without a proven benefit to the patient

because substantial clinical information

does not exist to support any other

claims.

The agency notes that neither the

classification panel nor the agency was

aware of any preamendments use of the

device for treatment of malignancies.

Therefore, when classifying this device,

the agency specifically excluded

treatment of malignancies from the

device identification. Accordingly, a

PMA or completed PDP is required

before this device may be marketed for

the treatment of malignancies,

irrespective of the date the new

requirements apply for all other uses.

3. Risks to Health

• Adverse tissue response that can

result in possible cataract formation in

the eye and central nervous system

injury.

• Electrical shock from excessive

leakage current from improper

grounding or a device malfunction.

•Burns from contact of uncovered

parts of the body at the device output

terminal or with inadequately insulated

cables and electrodes.

B. Ultrasonic Diathermy (21 CFR

890.5300(b))

1. Identification

An ultrasound diathermy device for

uses other than treatment of select

medical conditions such as relief of

pain, muscle spasms, and joint

contractures, is a device that applies to

the body ultrasonic energy at a

frequency beyond 20 kilohertz and that

is intended for the treatment of medical

conditions by means other than the

generation of deep heat within body

tissues. Use of this device does not

include use for the treatment of

malignancies.

2. Summary of Data

The panel recommended that the

device intended for applying

therapeutic deep heat be classified into

class II based on the potential hazards

associated with use of the device, on the

panel members’ knowledge of and
40680 Federal Register / Vol. 63, No. 146 /Thursday, July 30, 1998 / Proposed Rules

clinical experience with the device, and

pertinent literature. FDA agreed with

this recommendation for the above

intended use. FDA also was aware that

the device was being used for additional

purposes for which it had not been

shown to be safe and effective.

Accordingly, FDA believed the device

should also be classified with respect to

all other intended uses. For all other

intended uses other than applying deep

therapeutic heat for treatment of select

medical conditions, the agency still

believes that this device presents a

potential unreasonable risk of injury

without a proven benefit to the patient

because substantial clinical information

does not exist to support any other

claims.

The agency notes that neither the

classification panel nor the agency was

aware of any preamendments use of the

device for treatment of malignancies.

Therefore, when classifying this device,

the agency specifically excluded

treatment of malignancies from the

device identification. Accordingly, a

PMA or completed PDP is required

before this device may be marketed for

the treatment of malignancies,

irrespective of the date the new

requirements apply for all other uses.

3. Risks to Health

• Electrical shock due to faulty design

or malfunction.

•Burns from high density current.

• Inappropriate therapy from

inaccurate measurement of applied

energy.

•Cavitation (cellular destruction)

from inadequately uniform field

distribution or a lack of sufficient

external pressure on the device applied

to the skin.

C. Ultrasound and Muscle Stimulator

(21 CFR 890.5860(b))

1. Identification

An ultrasound and muscle stimulator

for uses other than treatment of select

medical conditions such as relief of

pain, muscle spasms, and joint

contractures, is a device that applies to

the body ultrasonic energy at a

frequency beyond 20 kilohertz bands

and applies to the body electrical

currents and that is intended for the

treatment of medical conditions by

means other than the generation of deep

heat within body tissues and the

stimulation or relaxation of muscles.

Use of this device does not include use

for the treatment of malignancies.

2. Summary of Data

The panel recommended that the

device intended to repeatedly contract

muscles by passing an electric current

through electrodes contacting the body

be classified into class II based on the

panel members’ knowledge of and

clinical experience with the device, and

pertinent literature. FDA agreed with

this recommendation for the above

intended use. FDA also was aware that

the device was being used for additional

purposes for which it had not been

shown to be safe and effective.

Accordingly, FDA believed the device

should also be classified with respect to

all other intended uses. For all other

intended uses other than applying deep

therapeutic heat for treatment of select

medical conditions, the agency still

believes that device presents a potential

unreasonable risk of injury without a

proven benefit to the patient because

substantial clinical information does not

exist to support any other claims.

The agency notes that neither the

classification panel nor the agency was

aware of any preamendments use of the

device for treatment of malignancies.

Therefore, when classifying this device,

the agency specifically excluded

treatment of malignancies from the

device identification. Accordingly, a

PMA or completed PDP is required

before this device may be marketed for

the treatment of malignancies,

irrespective of the date the new

requirements apply for all other uses.

3. Risks to Health

• Electrical shock due to faulty design

or malfunction.

•Cardiac arrest from excessive

electrical current passing through the

heart.

• Inappropriate therapy from

inaccurate measurement function.

V. PMA Requirements

A PMA for any of 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 above,

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 the following: (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

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 the

Center for Devices and Radiological

Health, Division of Small Manufacturers

Assistance (HFZ–220), Food and Drug

Administration, 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 the following: (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

the Center for Devices and Radiological

Health, Office of Device Evaluation

(HFZ–400), Food and Drug

Administration, 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
Federal Register / Vol. 63, No. 146 /Thursday, July 30, 1998 / Proposed Rules 40681

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 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

(5 U.S.C. 601–612), 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 Commissioner

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 Part 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 part 890 be amended as follows:

PART 890—PHYSICAL MEDICINE

DEVICES

1. The authority citation for 21 CFR

part 890 continues to read as follows:

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

360j, 371.

2. Section 890.5275 is amended by

revising paragraph (c) to read as follows:

§ 890.5275 Microwave diathermy.

* * * * *

(c) Date PMA or notice of completion

of PDP is required. A PMA or notice of

completion of a PDP for a device

described in paragraph (b) of this

section is required to be filed with the

Food and Drug Administration on or

before (date 90 days after date of

publication of the final rule) for any

microwave diathermy described in

paragraph (b) of this section 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), been found to be substantially

equivalent to a microwave diathermy

described in paragraph (b) of this

section that was in commercial

distribution before May 28, 1976. Any

other microwave diathermy described in

paragraph (b) of this section shall have

an approved PMA or declared

completed PDP in effect before being

placed in commercial distribution.

3. Section 890.5300 is amended by

revising paragraph (c) to read as follows:

§ 890.5300 Ultrasonic diathermy.

* * * * *

(c) Date PMA or notice of completion

of PDP is required. A PMA or notice of

completion of a PDP for a device

described in paragraph (b) of this

section is required to be filed with the

Food and Drug Administration on or

before (date 90 days after date of

publication of the final rule) for any

ultrasonic diathermy described in

paragraph (b) of this section 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), been found to be substantially

equivalent to an ultrasound diathermy

described in paragraph (b) of this

section that was in commercial

distribution before May 28, 1976. Any

other ultrasound diathermy described in

paragraph (b) of this section shall have

an approved PMA or declared

completed PDP in effect before being

placed in commercial distribution.

4. Section 890.5860 is amended by

revising paragraph (c) to read as follows:

§ 890.5860 Ultrasound and muscle

stimulator.

* * * * *

(c) Date PMA or notice of completion

of PDP is required. A PMA or notice of

completion of a PDP for a device

described in paragraph (b) of this

section is required to be filed with the

Food and Drug Administration on or

before (date 90 days after date of

publication of the final rule) for any

ultrasound and muscle stimulator

described in paragraph (b) of this

section 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), been

found to be substantially equivalent to

an ultrasound and muscle stimulator

described in paragraph (b) of this

section that was in commercial

distribution before May 28, 1976. Any

other ultrasound and muscle stimulator

described in paragraph (b) of this

section shall have an approved PMA or

declared completed PDP in effect before

being placed in commercial

distribution.

Dated: July 21, 1998.

Elizabeth D. Jacobson,

Deputy Director for Science, Center for

Devices and Radiological Health.

[FR Doc. 98–20306 Filed 7–29–98; 8:45 am]

BILLING CODE 4160–01–F