[Federal Register Volume 64, Number 71 (Wednesday, April 14, 1999)]
[Rules and Regulations]
[Pages 18329-18331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-9220]


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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]
BILLING CODE 4160-01-F