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

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: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final

rule 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 medical

devices: The microwave diathermy device for uses other than treatment

of select medical conditions, such as relief of pain, muscle spasms,

and joint contractures; the ultrasonic diathermy device for uses other

than treatment of select medical conditions, such as relief of pain,

muscle spasms, and joint contractures; and the ultrasound and muscle

stimulator device 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 has summarized its 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. This action is being taken under the Federal Food, Drug,

and Cosmetic Act (the act) as amended by the Medical Device Amendments

of 1976 (the amendments), the Safe Medical Devices Act of 1990 (the

SMDA), and the Food and Drug Administration Modernization Act of 1997

(FDAMA).

EFFECTIVE DATE: April 14, 1999.

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 Safe Medical Devices Act of 1990 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 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.

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 document 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

[[Page 18330]]

three groups as referenced in the May 6, 1994, notice.

In the Federal Register of July 30, 1998 (63 FR 40677), FDA

published a proposed rule (hereinafter referred to as the July 1998

proposed rule) to require the filing of a PMA or a notice of completion

of a PDP for the microwave diathermy device (Sec. 890.5275(b) (21 CFR

890.5275(b))), ultrasonic diathermy device (Sec. 890.5300(b) (21 CFR

890.5300(b))), and ultrasound and muscle stimulator (Sec. 890.5860(b)

(21 CFR 890.5860(b))), three high priority group 3 physical medicine

devices. In accordance with section 515(b)(2)(A) of the act, FDA

included in the preamble to the proposal the agency's proposed findings

with respect to the degree of risk of illness or injury designed to be

eliminated or reduced by requiring the device to meet the premarket

approval requirements of the act, and the benefits to the public from

use of the device.

The preamble to the July 1998 proposed rule also provided an

opportunity for interested persons to submit comments on the proposed

rule and the agency's findings, and under section 515(b)(2)(B) of the

act, FDA provided an opportunity for interested persons to request a

change in the classification of the device based on new information

relevant to its classification. Any petition requesting a change in the

classification of the devices was required to be submitted by August

13, 1998. The comment period closed October 28, 1998. The agency did

not receive any comments or petitions requesting a change in the

classification of these devices.

II. Findings with Respect to Risks and Benefits

Under section 515(b)(3) of the act, FDA is adopting the findings as

published in the July 1998 proposed rule. As required by section 515(b)

of the act, FDA published its 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

device.

These findings are based on the reports and recommendations of the

Orthopedic and Rehabilitation Devices Panel, an FDA advisory committee,

for the classification of the devices along with any additional

information FDA discovered. Additional information can be found in the

proposed and final rules classifying the devices in the Federal

Register on August 28, 1979 (44 FR 50458) and November 23, 1983 (49 FR

53032), respectively.

III. Final Rule

Under section 515(b)(3) of the act, FDA is adopting the findings as

published in the preamble to the proposed rule and issuing this final

rule to require premarket approval of the generic type of devices for

class III preamendment devices by revising Secs. 890.5275(c),

890.5300(c), and 890.5860(c).

Under the final rule, a PMA or a notice of completion of a PDP is

required to be filed on or before July 13, 1999, for any of these class

III preamendment devices that were in commercial distribution before

May 28, 1976, or that have been found by FDA to be substantially

equivalent to such a device on or before July 13, 1999. An approved PMA

or a declared completed PDP is required to be in effect for any such

devices on or before 180 days after FDA files the application. Any

other class III preamendment device subject to this rule that was not

in commercial distribution before May 28, 1976, is required to have an

approved PMA or a declared completed PDP in effect before it may be

marketed.

If a PMA or a notice of completion of a PDP for any of these class

III preamendment devices is not filed on or before the 90th day past

the effective date of this regulation, that device will be deemed

adulterated under section 501(f)(1)(A) of the act (21 U.S.C.

351(f)(1)(A)), and commercial distribution of the device will be

required to cease immediately. The device may, however, be distributed

for investigational use, if the requirements of the investigational

device exemption (IDE) regulations (part 812 (21 CFR part 812)) are

met.

Under Sec. 812.2(d) of the IDE regulations, FDA hereby stipulates

that the exemptions from the IDE requirements in Sec. 812.2(c)(1) and

(c)(2) will no longer apply to clinical investigations of these class

III preamendment devices. Further, FDA concludes that investigational

class III preamendment devices are significant risk devices as defined

in Sec. 812.3(m) and advises that as of the effective date of

Secs. 890.5275(c), 890.5300(c), and 890.5860(c), the requirements of

the IDE regulations regarding significant risk devices will apply to

any clinical investigation of these preamendment devices. For any of

these class III preamendment devices that is not subject to a timely

filed PMA or PDP, an IDE must be in effect under Sec. 812.20 on or

before 90 days after the effective date of this regulation or

distribution of the device must cease. FDA advises all persons

presently sponsoring a clinical investigation involving any of these

class III preamendment devices to submit an IDE application to FDA no

later than 60 days after the effective date of this final rule to avoid

the interruption of ongoing investigations.

IV. 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.

V. Analysis of Impacts

FDA has examined the impacts of the final 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 final rule is consistent with

the regulatory philosophy and principles identified in the Executive

Order. In addition, the final 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 final rule will not have a significant economic impact on a

substantial number of small entities. Therefore, under the Regulatory

Flexibility Act, no further analysis is required.

VI. Paperwork Reduction Act of 1995

FDA concludes that this final rule does not contain collection of

information provisions. 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.

[[Page 18331]]

Therefore, under the Federal Food, Drug, and Cosmetic Act and under

authority delegated to the Commissioner of Food and Drugs, 21 CFR part

890 is 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:

Sec. 890.5275 Microwave diathermy.

* * * * *

(c) Date PMA or notice of completion of PDP is required. A PMA or a

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 July 13, 1999, 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 July 13,

1999, 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:

Sec. 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 July 13, 1999, 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 July 13,

1999, been found to be substantially equivalent to an ultrasonic

diathermy described in paragraph (b) of this section that was in

commercial distribution before May 28, 1976. Any other ultrasonic

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:

Sec. 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 July 13, 1999 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

July 13, 1999, 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: April 7, 1999.

William K. Hubbard,

Acting Deputy Commissioner for Policy.

[FR Doc. 99-9220 Filed 4-13-99; 8:45 am]

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