[Federal Register Volume 63, Number 146 (Thursday, July 30, 1998)]
[Proposed Rules]
[Pages 40673-40677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20311]
[[Page 40673]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 874 and 882
[Docket No. 98N-0405]
Medical Devices; Retention in Class III and Effective Date of
Requirement for Premarket Approval for Three Preamendments Class III
Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; opportunity to request a change in
classification.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to retain
in class III, three preamendments class III medical devices, and is
proposing to require the filing of a premarket approval application
(PMA) or a notice of completion of a product development protocol (PDP)
for these devices. FDA believes that the suction antichoke device, the
tongs antichoke device, and the implanted neuromuscular stimulator
device should remain in class III because insufficient information
exists to determine that special controls would provide reasonable
assurance of their safety and effectiveness, and/or these devices
present a potential unreasonable risk of illness or injury. The agency
is summarizing its proposed findings regarding the degree of risk of
illness or injury designed to be eliminated or reduced by requiring the
devices to meet the statute's approval requirements and the benefits to
the public from the use of the devices. In addition, FDA is announcing
the opportunity for interested persons to request the agency to change
the classification of any of the devices based on new information.
DATES: Written comments by October 28, 1998; request for a change in
classification by August 14, 1998. FDA intends that, if a final rule
based on this proposed rule is issued, PMA's will be required to be
submitted within 90 days of the effective date of the final rule.
ADDRESSES: Written comments or requests for a change in classification
to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Janet L. Scudiero, Center for Devices
and Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1184.
SUPPLEMENTARY INFORMATION:
I. Background
The Federal Food, Drug, and Cosmetic Act (the act), as amended by
the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L.
94-295) and the Safe Medical Devices Act of 1990 (the SMDA) (Pub. L.
101-629), established a comprehensive system for the regulation of
medical devices intended for human use. Section 513 of the act (21
U.S.C. 360c) established three categories (classes) of devices,
depending on the regulatory controls needed to provide reasonable
assurance of their safety and effectiveness. The three categories of
devices are class I (general controls), class II (special controls),
and class III (premarket approval).
Under section 513 of the act, devices that were in commercial
distribution before May 28, 1976 (the date of enactment of the 1976
amendments), generally referred to as preamendments devices, are
classified after FDA has: (1) Received a recommendation from a device
classification panel (an FDA advisory committee); (2) published the
panel's recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
Devices that were not in commercial distribution prior to May 28,
1976, generally referred to as postamendments devices, are classified
automatically by statute (section 513(f) of the act) into class III
without any FDA rulemaking process. Those devices remain in class III
and require premarket approval, unless and until the device is
reclassified into class I or II or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the act, to a predicate device that does not require
premarket approval. The agency determines whether new devices are
substantially equivalent to previously offered devices by means of
premarket notification procedures in section 510(k) of the act (21
U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
Section 515(b)(1) of the act (21 U.S.C. 360e(b)(1)) established the
requirement that a preamendments device that FDA has classified into
class III is subject to premarket approval. A preamendments class III
device may be commercially distributed without an approved PMA or a
notice of completion of a PDP until 90 days after FDA issues a final
rule requiring premarket approval for the device, or 30 months after
final classification of the device under section 513 of the act,
whichever is later. Also, a preamendments device subject to the
rulemaking procedure under section 515(b) of the act is not required to
have an approved investigational device exemption (IDE) (see 21 CFR
part 812) contemporaneous with its interstate distribution until the
date identified by FDA in the final rule requiring the submission of a
PMA for the device. At that time, an IDE is required only if a PMA has
not been submitted or a PDP completed.
Section 515(b)(2)(A) of the act provides a proceeding to issue a
final rule to require premarket approval shall be initiated by
publication of a notice of proposed rulemaking containing: (1) The
proposed rule; (2) proposed findings with respect to the degree of risk
of illness or injury designed to be eliminated or reduced by requiring
the device to have an approved PMA or a declared completed PDP and the
benefit to the public from the use of the device; (3) an opportunity
for the submission of comments on the proposed rule and the proposed
findings; and (4) an opportunity to request a change in the
classification of the device based on new information relevant to the
classification of the device.
Section 515(b)(2)(B) of the act provides that if FDA receives a
request for a change in the classification of the device within 15 days
of the publication of the notice, FDA shall, within 60 days of the
publication of the notice, consult with the appropriate FDA advisory
committee and publish a notice denying the request for change in
reclassification or announcing its intent to initiate a proceeding to
reclassify the device under section 513(e) of the act. Section
515(b)(3) of the act provides that FDA shall, after the close of the
comment period on the proposed rule and consideration of any comments
received, issue a final rule to require premarket approval, or publish
a notice terminating the proceeding together with the reasons for such
termination. If FDA terminates the proceeding, FDA is required to
initiate reclassification of the device under section 513(e) of the
act, unless the reason for termination is that the device is a banned
device under section 516 of the act (21 U.S.C. 360f).
If a proposed rule to require premarket approval for a
preamendments device is finalized, section 501(f)(2)(B) of the act (21
U.S.C. 351(f)(2)(B)) requires that a PMA or notice of completion of a
PDP for any such device be filed within 90 days of the date of issuance
of the final rule or 30 months after the final classification of the
device under section 513 of the
[[Page 40674]]
act, whichever is later. If a PMA or notice of completion of a PDP is
not filed by the later of the two dates, commercial distribution of the
device is required to cease. The device may, however, be distributed
for investigational use if the manufacturer, importer, or other sponsor
of the device complies with the IDE regulations. If a PMA or notice of
completion of a PDP is not filed by the later of the two dates, and no
IDE is in effect, the device is deemed to be adulterated within the
meaning of section 501(f)(1)(A) of the act, and subject to seizure and
condemnation under section 304 of the act (21 U.S.C. 334) if its
distribution continues. Shipment of devices in interstate commerce will
be subject to injunction under section 302 of the act (21 U.S.C. 332),
and the individuals responsible for such shipment will be subject to
prosecution under section 303 of the act (21 U.S.C. 333). In the past,
FDA has requested that manufacturers take action to prevent the further
use of devices for which no PMA has been filed and may determine that
such a request is appropriate for the class III devices that are the
subjects of this regulation.
The act does not permit an extension of the 90-day period after
issuance of a final rule within which an application or a notice is
required to be filed. The House Report on the 1976 amendments states
that ``the thirty month `grace period' afforded after classification of
a device into class III * * * is sufficient time for manufacturers and
importers to develop the data and conduct the investigations necessary
to support an application for premarket approval.'' (H. Rept. 94-853,
94th Cong., 2d sess. 42 (1976).)
The SMDA added new section 515(i) to the act (21 U.S.C. 360e(i)).
This section requires FDA to review the classification of preamendments
class III devices for which no final rule has been issued requiring the
submission of PMA's and to determine whether or not each device should
be reclassified into class I or class II or remain in class III. For
devices remaining in class III, SMDA directed FDA to develop a schedule
for issuing regulations to require premarket approval. SMDA does not,
however, prevent FDA from proceeding immediately to rulemaking under
section 515(b) of the act on specific devices, in the interest of
public health, independent of the procedures of section 515(i). Indeed,
proceeding directly to rulemaking under section 515(b) of the act is
consistent with Congress' objective in enacting section 515(i), i.e.,
that preamendments class III devices for which PMA's have not been
required either be reclassified to class I or class II or be subject to
the requirements of premarket approval. Moreover, in this proposal,
interested persons are being offered the opportunity to request
reclassification of any of the devices.
In the Federal Register of May 6, 1994 (59 FR 23731), FDA issued a
notice of availability of a preamendments class III devices strategy
document. The strategy set forth FDA's plans for implementing the
provisions of section 515(i) of the act for preamendments class III
devices for which FDA had not yet required premarket approval. FDA
divided this universe of devices into three groups:
1. Group 1 devices are devices that FDA believes raise significant
questions of safety and/or effectiveness but are no longer used or are
in very limited use. FDA's strategy is to call for PMA's for all Group
1 devices in an omnibus 515(b) rulemaking action. In the Federal
Register of September 7, 1995 (60 FR 46718), FDA implemented this
strategy by proposing to require the filing of a PMA or a notice of
completion of a PDP for 43 class III preamendments devices.
Subsequently, in the Federal Register of September 27, 1996 (61 FR
50704), FDA called for the filing of a PMA or a notice of completion of
a PDP for 41 preamendments class III devices. Due to public comment,
the agency is reconsidering its position on the two remaining devices
subject to the September 7, 1995, proposal.
2. Group 2 devices are devices that FDA believes have a high
potential for being reclassified into class II. In the Federal Register
of August 14, 1995 (60 FR 41986), and of June 13, 1997 (62 FR 32355),
FDA issued an order under section 515(i) of the act requiring
manufacturers to submit safety and effectiveness information on these
Group 2 devices so that FDA can make a determination as to whether the
devices should be reclassified.
3. Group 3 devices are devices that FDA believes are currently in
commercial distribution and are not likely candidates for
reclassification. FDA intends to issue proposed rules to require the
submission of PMA's for the 15 high priority devices in this group in
accordance with the schedule set forth in the strategy document. In the
Federal Register of August 14, 1995 (60 FR 41984), and of June 13, 1997
(62 FR 32352), FDA issued an order under section 515(i) of the act for
the 27 remaining Group 3 devices requiring manufacturers to submit
safety and effectiveness information so that FDA can make a
determination as to whether the devices should be reclassified or
retained in class III. This proposed rule would further implement the
strategy by retaining the three devices in class III (referred to
previously) and requiring manufacturers of such devices to submit PMA's
or completed PDP's for the devices.
II. Dates New Requirements Apply
In accordance with section 515(b) of the act, FDA is proposing to
require that a PMA or a notice of completion of a PDP be filed with the
agency for class III devices within 90 days after issuance of any final
rule based on this proposal. An applicant whose device was legally in
commercial distribution before May 28, 1976, or whose device has been
found to be substantially equivalent to such a device, will be
permitted to continue marketing such class III devices during FDA's
review of the PMA or notice of completion of the PDP. FDA intends to
review any PMA for the device within 180 days, and any notice of
completion of a PDP for the device within 90 days of the date of
filing. FDA cautions that, under section 515(d)(1)(B)(i) of the act,
the agency may not enter into an agreement to extend the review period
for a PMA beyond 180 days unless the agency finds that ``* * * the
continued availability of the device is necessary for the public
health.''
FDA intends that, under Sec. 812.2(d) (21 CFR 812.2(d)), the
preamble to any final rule based on this proposal will state that, as
of the date on which the filing of a PMA or a notice of completion of a
PDP is required to be filed, the exemptions in 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
[[Page 40675]]
should be submitted to FDA at least 30 days before the end of the 90-
day period after the final rule to avoid interrupting investigations.
III. Proposed Findings With Respect to Risks and Benefits
As required by section 515(b) of the act, FDA is publishing its
proposed findings regarding: (1) The degree of risk of illness or
injury designed to be eliminated or reduced by requiring that these
devices have an approved PMA or a declared completed PDP, and (2) the
benefits to the public from the use of the devices.
These findings are based on the reports and recommendations of the
advisory committees (panels) for the classification of these devices
along with any additional information that FDA discovered. Additional
information can be found in the proposed and final rules published in
the Federal Register classifying these devices: On January 22, 1982
(47 FR 3280), and November 6, 1986 (51 FR 40378), for ear, nose, and
throat devices (part 874 (21 CFR part 874)); and on November 28, 1978
(43 FR 55640), and September 4, 1979 (44 FR 51726), for neurological
devices (part 882 (21 CFR part 882)).
IV. Devices Subject to This Proposal
A. Suction antichoke device (Sec. 874.5350)
1. Identification
A suction antichoke device is a device intended to be used in an
emergency situation to remove, by the application of suction, foreign
objects that obstruct a patient's airway to prevent asphyxiation to the
patient.
2. Summary of Data
The Ear, Nose, and Throat Devices Classification Panel (the panel)
recommended that the suction antichoke device intended to be used in an
emergency situation to remove foreign objects that obstruct a patient's
airway to prevent asphyxiation to the patient be classified into class
III based on an unpublished study that showed unsuccessful performance
of the device. FDA agreed and continues to agree with the panel's
recommendation. FDA also notes that the agency received no 515(i)
submissions of safety and effectiveness information on the device and
that although there was one premarket notification for the device in
1979, the device appears to have fallen into disuse. The agency also
realizes that the Heimlich Maneuver is now recognized as the best way
to assist a choking victim.
3. Risks to Health
Failure of the device to perform as intended could result in
asphyxiation of the patient. The effectiveness of the suction feature
of this device for the removal of foreign objects from an obstructed
airway is questionable. Certain designs of the device have been shown
to be ineffective.
B. Tongs antichoke device (Sec. 874.5370)
1. Identification
A tongs antichoke device is a device intended to be used in an
emergency situation to grasp and remove foreign objects that obstruct a
patient's airway to prevent asphyxiation to the patient. This generic
type of device includes a plastic instrument with serrated ends that is
inserted into the airway in a blind manner to grasp and extract foreign
objects, and a stainless steel forceps with spoon ends that is inserted
under tactile guidance to grasp and extract foreign objects from the
airway.
2. Summary of data
The Ear, Nose, and Throat Devices Classification Panel (the panel)
recommended that the tongs antichoke device intended to remove foreign
objects that obstruct a patient's airway to prevent asphyxiation to the
patient be classified into class III based on an unpublished study that
showed that the device may grasp an anatomical structure of the body
rather than the obstructing foreign object and that the foreign object
would not be extracted. FDA agreed and continues to agree with the
panel's recommendation. FDA also notes that the agency received no
515(i) submissions of safety and effectiveness information on the
device, and that the device appears to have fallen into disuse. The are
no premarket notification submissions for the device. The agency also
realizes that the Heimlich Maneuver is now recognized as the best way
to assist a choking victim.
3. Risks to health
a. Asphyxiation. The use of the generic type of device on a patient
with a partial obstruction may force the obstruction further down the
airway, causing complete obstruction.
b. Damage to anatomical structures. Anatomical structures grasped
by the tongs can be torn or ruptured. (Risk is associated primarily
with plastic tongs with serrated ends.)
c. Panic. Injured and bleeding anatomical structures may result in,
or contribute to panic of the patient. (Risk is associated primarily
with plastic tongs with serrated ends.)
C. Implanted neuromuscular stimulator (Sec. 882.5860)
1. Identification
An implanted neuromuscular stimulator is a device that provides
electrical stimulation to a patient's peroneal or femoral nerve to
cause muscles in the leg to contract, thus improving the gait in a
patient with a paralyzed leg. The stimulator consists of an implanted
receiver with electrodes that are placed around a patient's nerve and
an external transmitter for transmitting the stimulation pulses across
the patient's skin to the implanted receiver. The external transmitter
is activated by a switch in the heel of the patient's shoe.
2. Summary of data
The Neurology Devices Classification Panel recommended that the
device intended to be implanted to improve the gait of a paralyzed
patient be classified into class III. The Orthopedics Devices
Classification Panel recommended that the device be classified into
class II. Both classification panels based their recommendations on
their personal knowledge of the device, the potential hazards
associated with the device, pertinent literature, and their clinical
experience with the device. FDA agreed and continues to agree with the
recommendation of the Neurology Devices Classification Panel. The
agency noted that only limited clinical data on the device was then
available. FDA also notes that there were no 515(i) submissions of
safety and effectiveness information on the device and that the device
appears to have fallen into disuse. There are no premarket notification
submissions for the device.
3. Risks to health
a. Tissue toxicity. The materials in the implanted components of
the device may cause a toxic or an adverse reaction in the surrounding
tissue.
b. Infection. There is an increased risk of sepsis associated with
the implantation of a foreign object in the body.
c. Injury to the nerve. The presence of the electrode or the output
current may injure the peroneal or femoral nerve.
V. PMA Requirements
A PMA for these devices must include the information required by
section 515(c)(1) of the act. Such a PMA should also include a detailed
discussion of the risks identified previously, as well as a discussion
of the effectiveness of the device for which premarket approval is
sought. In addition, a PMA must include all data and information on:
(1)
[[Page 40676]]
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 FDA, Center for Devices and Radiological Health, Division
of Small Manufacturers Assistance (HFZ-220), 1350 Piccard Dr.,
Rockville, MD 20850. This manual is also available on the World Wide
Web at ``http://www.fda.gov/cdrh''.
VI. PDP Requirements
A PDP for any of these devices may be submitted in lieu of a PMA,
and must follow the procedures outlined in section 515(f) of the act. A
PDP should provide: (1) A description of the device; (2) preclinical
trial information (if any); (3) clinical trial information (if any);
(4) a description of the manufacturing and processing of the devices;
(5) the labeling of the device; and (6) all other relevant information
about the device. In addition, the PDP must include progress reports
and records of the trials conducted under the protocol on the safety
and effectiveness of the device for which the completed PDP is sought.
Applicants should submit any PDP in accordance with FDA's ``PDP
Comprehensive Outline with Attachments.'' This Outline is available
upon request from FDA, Center for Devices and Radiological Health,
Office of Device Evaluation (HFZ-400), 9200 Corporate Blvd., Rockville,
MD 20850. The outline and other PDP information is also available on
the World Wide Web at ``http://www.fda.gov/cdrh/pdp''.
VII. Request for Comments with Data
Interested persons may, on or before October 28, 1998, submit to
the Dockets Management Branch (address above) written comments
regarding this proposal. Two copies of any comments are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
VIII. Opportunity to Request a Change in Classification
Before requiring the filing of a PMA or notice of completion of a
PDP for a device, FDA is required by section 515(b)(2)(A)(i) through
(b)(2)(A)(iv) of the act and 21 CFR 860.132 to provide an opportunity
for interested persons to request a change in the classification of the
device based on new information relevant to the classification. Any
proceeding to reclassify the device will be under the authority of
section 513(e) of the act.
A request for a change in the classification of these devices is to
be in the form of a reclassification petition containing the
information required by 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.
IX. Environmental Impact
The agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
X. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the proposed
rule is not a significant regulatory action as defined by the Executive
Order and so is not subject to review under the Executive Order.
If a rule has a significant economic impact on a substantial number
of small entities, the Regulatory Flexibility Act requires agencies to
analyze regulatory options that would minimize any significant impact
of a rule on small entities. Because FDA believes that there is little
or no interest in marketing these devices, the agency certifies that
the proposed rule, if issued as a final rule, will not have a
significant impact on a substantial number of small entities.
Therefore, under the Regulatory Flexibility Act, no further analysis is
required.
XI. Paperwork Reduction Act of 1995
FDA tentatively concludes that this proposed rule contains no
collections of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.
List of Subjects in 21 CFR Parts 874 and 882
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR parts 874 and 882 be amended as follows:
PART 874--EAR, NOSE, AND THROAT DEVICES
1. The authority citation for 21 CFR part 874 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
2. Section 874.5350 is amended by revising paragraph (c) to read as
follows:
Sec. 874.5350 Suction antichoke device.
* * * * *
(c) Date PMA or notice of completion of PDP is required. A PMA or
notice of completion of a PDP is required to be filed with the Food and
Drug Administration on or before (date 90 days after date of
publication of the final rule based on this proposed rule) for any
suction antichoke device that was in commercial distribution before May
28, 1976, or that has, on or before (date 90 days after date of
publication of the final rule based on this proposed rule), been found
to be substantially equivalent to a suction antichoke device that was
in commercial distribution before May 28, 1976. Any other suction
antichoke
[[Page 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:
Sec. 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:
Sec. 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