[Federal Register: July 30, 1998 (Volume 63, Number 146)]
[Proposed Rules]
[Page 40677-40681]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30jy98-26]

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

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).

[[Page 40678]]

    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

[[Page 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 Sec. 812.2(d), the preamble to any final
rule based on this proposal will state that, as of the date on which
the filing of a PMA or a notice of completion of a PDP is required to
be filed, the exemptions in Sec. 812.2(c)(1) and (c)(2) from the
requirements of the IDE regulations for preamendments class III devices
will cease to apply to any device that is: (1) Not legally on the
market on or before that date, or (2) legally on the market on or
before that date but for which a PMA 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
    <bullet> Adverse tissue response that can result in possible
cataract formation in the eye and central nervous system injury.
    <bullet> Electrical shock from excessive leakage current from
improper grounding or a device malfunction.
    <bullet> 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

[[Page 40680]]

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
    <bullet> Electrical shock due to faulty design or malfunction.
    <bullet> Burns from high density current.
    <bullet> Inappropriate therapy from inaccurate measurement of
applied energy.
    <bullet> 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
    <bullet> Electrical shock due to faulty design or malfunction.
    <bullet> Cardiac arrest from excessive electrical current passing
through the heart.
    <bullet> 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 well-
controlled clinical studies, with detailed data, in order to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use. (See 21 CFR 860.7(c)(2).)
    Applicants should submit any PMA in accordance with FDA's
``Premarket Approval (PMA) Manual.'' This manual is available upon
request from 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

[[Page 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 Sec. 860.123 (21 CFR 860.123), including new
information relevant to the classification of the device, and shall,
under section 515(b)(2)(B) of the act, be submitted by 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
Sec. 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:

Sec. 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:

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 (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:

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 (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