[Federal Register Volume 61, Number 67 (Friday, April 5, 1996)]
[Rules and Regulations]
[Pages 15186-15190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8361]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 814

[Docket No. 93N-0047]
RIN 0910-AA09


Medical Devices; Temporary Suspension of Approval of a Premarket 
Approval Application

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is establishing 
procedures to order the temporary suspension of approval of a premarket 
approval application (PMA) for a medical device. This action is being 
taken under a new authority granted to the agency by the Safe Medical 
Devices Act of 1990 (the SMDA). Under this new authority, if, after 
providing an opportunity for an informal hearing, FDA determines there 
is a reasonable probability that continued distribution of a device 
would cause serious, adverse health consequences or death, the agency 
shall, by order, temporarily suspend approval of a PMA, and proceed 
expeditiously, but within 60 days, to permanently withdraw approval of 
the PMA. The final rule also clarifies that these procedures apply to 
an original PMA, as well as any PMA supplement(s), for a medical 
device.
EFFECTIVE DATE: May 6, 1996.
FOR FURTHER INFORMATION CONTACT: Lisa A. Rooney, Center for Devices and 
Radiological Health (HFZ-84), Food and Drug Administration, 2094 
Gaither Rd., Rockville, MD 20850, 301-594-4765, ext. 164.
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 12, 1993 (58 FR 52729), FDA 
published a proposed rule to establish procedures to order the 
temporary suspension of approval of a PMA for a medical device. 
Interested persons were given until December 13, 1993, to comment on 
the proposed rule. The agency received four comments, one from a trade 
association, and three from manufacturers.

II. Summary of the Final Rule

    Section 9 of the SMDA (Pub. L. 101-629) amended section 515(e) of 
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(e)) 
by adding section 515(e)(3) of the act which provides the agency with 
the authority to temporarily suspend approval of a PMA. This authority 
applies to the original PMA, as well as any PMA supplement(s), for a 
medical device. Section 515(e)(3) of the act and new Sec. 814.47, the 
implementing regulation, provide the agency with a prompt method of 
removing dangerous devices from the market pending resolution of 
permanent PMA or PMA supplement withdrawal proceedings.
    Under Sec. 814.47(a), FDA will issue an order temporarily 
suspending approval of a PMA or a PMA supplement when FDA determines 
that there is a reasonable probability that continued distribution of 
the device would cause serious, adverse health consequences or death.
    Pursuant to Sec. 814.47(b), when FDA makes the requisite 
determination, FDA shall provide an opportunity for an informal hearing 
to determine whether to issue an order temporarily suspending approval 
of a PMA or a PMA supplement. Such an informal hearing is to be 
initiated and conducted by FDA pursuant to part 16 (21 CFR part 16). 
Generally, under Sec. 814.47(b)(2), the person provided with notice of 
an opportunity for an informal hearing will have not less than 3 
working days after receipt of the notice to request a hearing. 
Moreover, the informal hearing ordinarily will not be held less than 2 
working days after receipt of the request for the hearing, in order to 
provide time for preparation. However, in those rare circumstances when 
FDA believes that immediate action to remove a dangerous device from 
the market is necessary to protect the public health, the agency may 
waive, suspend, or modify the above-referenced timeframes in accordance 
with Sec. 10.19 (21 CFR 10.19) and Sec. 16.60(h).
    Under Sec. 814.47(b)(3), a PMA holder's or a PMA supplement 
holder's failure to request a hearing within the timeframe specified by 
FDA in the notice of opportunity for a hearing, which is generally not 
less than 3 working days, is deemed a waiver of the hearing.

[[Page 15187]]

    Pursuant to Sec. 814.47(c), if the PMA or PMA supplement holder 
does not request a hearing or after an informal hearing, FDA shall, by 
order, temporarily suspend approval of a PMA or PMA supplement if the 
agency determines there is a reasonable probability that continued 
distribution of the device would cause serious, adverse health 
consequences or death. In accordance with Sec. 814.47(d), FDA shall 
proceed expeditiously, but within 60 days, to permanently withdraw 
approval of the PMA or PMA supplement.

III. Clarification of the Proposed Rule

    This final rule clarifies that the procedures for ordering the 
temporary suspension of approval of a PMA apply to both the original 
PMA and any PMA supplement(s) for a medical device. A PMA supplement is 
a supplemental application for approval of a change affecting the 
safety or effectiveness of a device for which there is an approved PMA 
(see Secs. 814.3(g) and 814.39). As discussed in the preamble to part 
814 (21 CFR part 814) (51 FR 26342 at 26354, July 22, 1986), when an 
applicant submits a PMA supplement for a change in an approved device, 
the applicant has, in effect, submitted a new PMA for the ``new'' 
(changed) device. For this reason, FDA has concluded that the authority 
provided by section 515(e)(3) of the act applies to both PMA's and PMA 
supplement(s).

IV.- Changes from the Proposed Rule

    Although the agency maintained the basic framework of the proposed 
rule, FDA modified the proposed rule in order to be consistent and 
compatible with the medical device recall authority and to address 
concerns raised in the comments. Several comments raised due process 
concerns that resulted in FDA clarifying proposed Sec. 814.47(b) and 
modifying proposed Sec. 814.47(d).
    FDA clarified that the hearing provided for in Sec. 814.47(b) will 
be conducted, whenever possible, in accordance with the procedures set 
out in part 16. Thus, under Sec. 814.47(b)(2), the person offered an 
opportunity for an informal hearing ordinarily will have not less than 
3 working days after receipt of the notice to request a hearing. 
Moreover, the informal hearing ordinarily will not be held less than 2 
working days after receipt of the request for the hearing. However, in 
extraordinary cases, if FDA believes that immediate action to remove a 
dangerous device from the market is necessary to protect the public 
health, the agency may waive, suspend, or modify the above-referenced 
timeframes in accordance with Sec. 10.19 and 16.60(h). -
    Furthermore, FDA amended Sec. 814.47(d) to specify a timeframe 
within which FDA must initiate permanent withdrawal of PMA or PMA 
supplement approval after issuing an order temporarily suspending PMA 
or PMA supplement approval. FDA concluded that following issuance of an 
order temporarily suspending approval of a PMA or a PMA supplement, the 
agency will proceed expeditiously, but within 60 days, to permanently 
withdraw approval of the PMA or the PMA supplement.

V. -Relationship Between Temporary Suspension of Approval of a PMA 
or PMA Supplement and Medical Device Recall Authority

    The SMDA provided FDA with, among other things, the authority to 
issue orders to temporarily suspend the approval of a PMA or a PMA 
supplement and to recall medical devices.
    Section 8 of the SMDA amended section 518 of the act (21 U.S.C. 
360h) by adding a new subsection (e) entitled ``Recall Authority.'' 
Section 518(e)(1) of the act provides that, if FDA finds that there is 
a reasonable probability that a device intended for human use would 
cause serious, adverse health consequences or death, FDA shall issue an 
order requiring the appropriate person to immediately cease 
distribution of the device, immediately notify health professionals and 
device user facilities of the order, and instruct such professionals 
and facilities to cease use of the device. Section 518(e)(2) of the act 
states that, after providing an opportunity for an informal hearing, 
FDA may amend the cease distribution and notification order to require 
a recall of the device. FDA's medical device recall authority may be 
invoked for any class of device.
    This recall authority may be invoked for targeted purposes, for 
example, when FDA wants an individual to temporarily cease distribution 
and/or recall certain lots, batches, or models of class I, class II, or 
class III devices which are located either in-house or on the market 
until such devices are brought into compliance; or, the recall 
authority may be used more broadly to cease distribution and/or recall 
all models, batches, or lots of a manufacturer's device. On the other 
hand, the agency's authority to temporarily suspend approval of a PMA 
or a PMA supplement is invoked only in the latter circumstance, when 
FDA wants a manufacturer to cease marketing all models, batches, or 
lots of a particular class III device which was approved under the 
subject PMA or PMA supplement, pending permanent withdrawal of the 
device's PMA or PMA supplement approval. Thus, there may be 
circumstances in which FDA could invoke both authorities.
    The threshold criteria for invoking the medical device recall 
authority and the authority to temporarily suspend approval of a PMA or 
PMA supplement are identical. Under both authorities, FDA will issue 
orders only when FDA determines there is a reasonable probability that 
continued distribution of a device would cause serious, adverse health 
consequences or death. Furthermore, under both authorities, FDA must 
provide the person subject to the order and the holder of the approved 
PMA or PMA supplement for the device with an opportunity for an 
informal hearing. In both situations, the informal hearing is to be 
conducted by FDA pursuant to part 16.
    If FDA determines that there is a reasonable probability that 
continued distribution of a currently marketed class III medical device 
would cause serious, adverse health consequences or death, the agency 
may invoke its medical device recall authority as well as its authority 
to temporarily suspend approval of the PMA or PMA supplement for the 
device. If both authorities are invoked, the medical device recall 
informal hearing will be combined with the temporary suspension of 
approval of a PMA or PMA supplement informal hearing. This combined 
informal hearing will occur after FDA makes the requisite finding, 
issues a cease distribution and notification order, and issues a letter 
of intent to temporarily suspend approval of a PMA or PMA supplement. 
This combined informal hearing does not eliminate the PMA or PMA 
supplement holder's opportunity for an informal hearing prior to FDA 
permanently withdrawing approval of a PMA or PMA supplement (see 
section 515(e)(1) of the act).

VI. Summary and Analysis of Comments and FDA's Response

    1. -One comment noted that the proposed rule, which states that 
``FDA may initiate and conduct a regulatory hearing to determine 
whether to issue an order temporarily suspending approval of the PMA'' 
(Sec. 814.47(b)(1)), implies that FDA can use its own discretion in 
determining whether or not to hold a hearing prior to temporarily 
suspending PMA approval and is contrary to section 515(e)(1) and (e)(3) 
of the act and to the preamble of the proposed rule itself (see 58 FR

[[Page 15188]]
52729). Thus, it was urged that the final rule unequivocally state that 
FDA will provide the manufacturer with an opportunity for an informal 
hearing prior to temporarily suspending PMA approval.
    FDA agrees with this comment. Under final Sec. 814.47(b), FDA must 
give the PMA or PMA supplement holder notice and an opportunity for a 
regulatory hearing under part 16 prior to temporarily suspending PMA or 
PMA supplement approval. However, whether or not a regulatory hearing 
is actually conducted depends on the decision of the PMA or PMA 
supplement holder. If the PMA or PMA supplement holder does not request 
a regulatory hearing within the timeframe specified by FDA in the 
notice of opportunity for a hearing, then FDA may temporarily suspend 
approval of the PMA or PMA supplement without a hearing. On the other 
hand, if the PMA or PMA supplement holder requests the regulatory 
hearing within the timeframe specified by FDA in the notice of 
opportunity for a hearing, then FDA must conduct the hearing before 
temporarily suspending approval of the holder's PMA or PMA supplement.
    2.- Under Sec. 814.47(b)(2), if FDA believes that immediate action 
to remove a dangerous device from the market is necessary to protect 
the public health, FDA may, pursuant to Sec. 16.60(h), waive or modify 
any part 16 procedure in accordance with Sec. 10.19. A comment noted 
that in this situation FDA can waive Sec. 16.24(e), which states that a 
hearing may not be required to be held at a time less than 2 working 
days after receipt of the request for a hearing. This comment 
recommended that, at the very least, Sec. 16.60(h) should not apply to 
Sec. 16.24(e). Another comment urged that the agency should not be 
allowed, under Sec. 16.60(h), to waive the notice requirements of 
Sec. 16.24(e), which states that a hearing may not be required to be 
held at a time less than 2 working days after receipt of the request 
for a hearing and Sec. 16.22(b), which gives a person at least 3 days 
after receiving notice of an opportunity for a hearing to request one. 
The comment urged that waiver of these sections would violate a PMA 
holder's due process rights. Additionally, it was contended that 
Secs. 16.22(b) and 16.24(e) cannot be waived because Secs. 10.19 and 
16.60(h) do not permit FDA to waive notice requirements. The comment 
requested that FDA insert language granting an informal hearing as 
defined in section 201(x) of the act (21 U.S.C. 321(x)) and specifying 
that notice of at least 10 calendar days is required prior to the 
issuance of an order temporarily suspending approval of a PMA. This 
same comment noted that, under Sec. 10.19, waiver of prehearing 
requirements is only allowed ``if no participant will be prejudiced, 
the ends of justice will thereby be served, and the action is in 
accordance with the law.'' According to this comment, waiver of 
Secs. 16.22(b) and 16.24(e) would violate section 515(e)(3) of the act, 
which requires the opportunity for an informal hearing.
    FDA agrees that the hearing provided for in Sec. 814.47(b)(2) 
should be conducted, whenever possible, within the timeframes set out 
in part 16. Thus, in accordance with Sec. 16.22(b) of this chapter, 
under Sec. 814.47(b)(2), the person offered an opportunity for an 
informal hearing ordinarily will have not less than 3 working days 
after receipt of the notice to request a hearing. Furthermore, pursuant 
to Sec. 16.24(e), the informal hearing ordinarily will not be held less 
than 2 working days after receipt of the request for the hearing. 
However, under Sec. 16.60(h), the Commissioner or the presiding officer 
has the power to waive any part 16 provision. According to Sec. 10.19, 
part 16 provisions can only be suspended, modified, or waived if no 
participant will be prejudiced, the ends of justice will thereby be 
served, and the action is in accordance with the law. FDA can waive, 
modify, or suspend the timeframes associated with the regulatory 
hearings relating to suspension of PMA or PMA supplement approvals as 
long as the PMA or PMA supplement holder is given notice and an 
opportunity for an informal hearing as required by section 515(e)(3) of 
the act. In extraordinary cases, FDA could give the PMA holder notice, 
conduct a hearing, and render a decision on the same day. This would be 
consistent with Congress' intent that, for temporary suspension action, 
the informal hearing, when necessary, should be analogous to a 
temporary restraining order (TRO) hearing that could result in notice, 
a hearing, and a judicial decision in a single day if immediate action 
to remove a dangerous device from the market is absolutely necessary to 
protect the public health. (See H. Rept. 808, 101st Cong., 2d sess. 31 
(1990).) Expedited hearing procedures under section 513(e) of the act, 
therefore, would be in accordance with the law. However, FDA believes 
that most temporary suspension hearings will be conducted within the 
timeframes set out in part 16.
    3. Another comment stated that enacting this rule as proposed, 
i.e., authorizing FDA to suspend, modify, or waive any part 16 
procedures, would create a procedure whereby persons challenging recall 
orders would have greater opportunities to defend themselves than 
persons affected by PMA suspension orders.
    As noted above, FDA is seeking to make as consistent and parallel 
as possible the procedures for recalling a device and temporarily 
suspending approval of a PMA or PMA supplement. Moreover, it is 
important to point out the additional protections that exist for PMA 
holders. Under section 515(e)(1) of the act, FDA must provide notice 
and an opportunity for an informal hearing before issuing an order for 
permanent withdrawal of PMA or PMA supplement approval. Additionally, a 
PMA or PMA supplement holder may petition for review of a section 
515(e)(1) order pursuant to section 515(g) of the act. Section 
515(g)(1) of the act provides ``[u]pon petition for review of * * * an 
order * * * withdrawing approval of an [PMA] application * * * the 
Secretary shall * * * hold a hearing * * *. The panel or panels which 
considered the application * * * shall designate a member to appear and 
testify at any such hearing upon request of the Secretary, the 
petitioner, or the officer conducting the hearing * * *. Upon 
completion of such hearing and after considering the record established 
in such hearing, the Secretary shall issue an order either affirming 
the order subject to the hearing or reversing such order and, as 
appropriate, * * * reinstating the application's approval * * *.'' 
Thus, a PMA or PMA supplement holder is provided with additional 
opportunities for a hearing prior to permanent withdrawal of PMA or PMA 
supplement approval.
    4. Another comment suggested that FDA's reliance upon H. Rept. 808, 
101st Cong., 2d sess. 31 for authority to give notice, conduct a 
hearing, and render a judicial decision within 1 day is misplaced 
because this legislative history relates to hearings, not informal 
hearings.
    FDA disagrees with this comment. The hearing referred to in the 
legislative history clearly pertains to the informal hearing discussed 
in section 515(e)(3) of the act even though Congress used the term 
``hearing,'' rather than ``informal hearing'' in the legislative 
history. Moreover, FDA can give notice, conduct a hearing, and render a 
decision in 1 day and still satisfy the informal hearing requirements 
found in section 201(x) of the act. However, as discussed in response 
to comment 2 of this document, FDA anticipates that temporary 
suspension hearings will almost always be conducted in accordance with 
the timeframes set out in part 16.

[[Page 15189]]

    5.- A comment suggested that there is no need for this rule because 
FDA can simply request a PMA holder to immediately stop distributing 
the product or, if a PMA holder fails to comply with this request, FDA 
can issue an order under FDA's recall authority to stop distribution of 
a device which threatens the public health.
    FDA disagrees with this comment. Congress gave FDA two separate, 
though overlapping, authorities to remove dangerous devices from the 
market. FDA will use one or both of these mechanisms, depending upon 
particular circumstances. As noted earlier, FDA has made the two 
procedures as consistent and parallel as possible in order to minimize 
confusion should both authorities be invoked.
    6. -All comments noted that proposed Sec. 814.47(d) failed to 
define the term ``proceed expeditiously'' and requested that the final 
rule specify a timeframe within which FDA must initiate permanent 
withdrawal of PMA approval after issuing an order temporarily 
suspending PMA approval. The comments suggested that FDA begin the 
permanent withdrawal proceedings within 10 to 30 days after issuing the 
temporary suspension order and conclude the proceedings within 30 to 60 
days after issuing the temporary suspension order.
    FDA agrees with the goal expressed in these comments. FDA has 
concluded that following the issuance of an order temporarily 
suspending approval of a PMA or PMA supplement, the agency will proceed 
expeditiously, but within 60 days, to hold a hearing on whether to 
permanently withdraw approval of the PMA or PMA supplement. Based on 
prior experience, FDA has determined that 60 days is sufficient time 
for both a PMA holder and FDA to prepare for an informal hearing which 
is required to be held prior to permanently withdrawing approval of a 
PMA, if such a hearing is requested. Section 814.14(d) has been amended 
accordingly.
    7.- A comment requested that the ``serious, adverse health 
consequences'' definition found in proposed Sec. 814.3 be changed. It 
was suggested that the words ``long range'' be replaced with ``long 
term'' because ``long term'' is a phrase that is more precise, that 
conforms to the legislative history, and that is more familiar to 
medical device manufacturers. (See S. Rept. 513, 101st Cong., 2d sess. 
19 (1990).)
    FDA agrees with this comment. The legislative history surrounding 
section 515(e)(3) of the act states that the term ``serious, adverse 
health consequences'' means: any significant adverse experience 
attributable to a device, including those which may be either life-
threatening, or involve permanent or long-term injuries, but excluding 
those nonlife-threatening injuries which are temporary and reasonably 
reversible. (See S. Rept. 513, 101st Cong., 2d sess. 19 (1990).) The 
definition has been changed to reflect the legislative history 
definition.
    FDA also has revised the definition of serious, adverse health 
consequences in Sec. 814.3(l) by deleting the following sentence: 
``Injuries attributable to a device that are treatable and reversible 
by standard medical techniques, proximate in time to the injury, are 
not included within the term's definition.'' The legislative history 
makes clear that the idea captured in the second sentence of the 
proposed definition was intended only to further explain the type of 
injury that would trigger temporary suspension Id. FDA has made the 
same revision in the medical device recall regulation.
    8.- One comment said that the preamble to the proposed rule 
suggested that application of section 515(e)(3) of the act turns on the 
judgment of whether, if distribution of the devices continues, one or 
more individual devices would be more likely than not to cause serious, 
adverse health consequences or death. The comment stated that this 
statement in the preamble erroneously implies that one device is enough 
to allow FDA to order a temporary PMA suspension.
    FDA believes this comment misunderstands FDA's intent. FDA 
emphasizes that application of section 515(e)(3) of the act does not 
turn on whether a particular percentage of devices would cause serious, 
adverse health consequences or death, but rather on the judgment of 
whether it is more likely than not that serious, adverse health 
consequences or death will result if distribution of the device 
continues.
    9. A comment urged that the definition of ``reasonable 
probability'' found in proposed Sec. 814.3 be made consistent with the 
February 1988 CDRH Medical Device Reporting Questions and Answers 
document, p. 22, for reportable malfunctions, which defines ``likely'' 
in terms of both a qualitative and quantitative evaluation of the 
likelihood that a recurrence of the malfunction will cause or 
contribute to a death or serious injury.
    FDA disagrees with this comment. The legislative history of section 
515(e)(3) of the act states that a ``reasonable probability'' is ``one 
where it is more likely than not that the event will occur.'' (See S. 
Rept. 513, 101st Cong., 2d sess. 19 (1990).) The same ``reasonable 
probability'' definition has been incorporated in Sec. 814.3(k) for 
consistency.
    10.- A comment requested that the rule allow a manufacturer to 
voluntarily withdraw a product before FDA issues an order temporarily 
suspending approval of the PMA.
    FDA agrees that a manufacturer can voluntarily withdraw a PMA or 
PMA supplement before FDA issues an order temporarily suspending 
approval of the application. In fact, FDA will ordinarily encourage the 
manufacturer to voluntarily withdraw its application before FDA issues 
a temporary suspension order. However, if FDA's attempts are 
unsuccessful or if FDA chooses not to urge voluntary withdrawal 
initially, FDA will follow the procedures for temporarily suspending 
approval of the manufacturer's PMA or PMA supplement. Because a 
voluntary withdrawal of the application renders moot the need for FDA 
to suspend its approval, there is no need to include this procedure in 
the final rule.

VII. Environmental Impact

    The agency has determined under 21 CFR 25.24(a)(8) 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.

VIII. 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). 
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.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because this rule only establishes the procedures by 
which FDA will implement its authority for the temporary suspension of 
approval of premarket approval applications, by

[[Page 15190]]
itself it imposes no burdens on manufacturers. Thus, 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.

List of Subjects in 21 CFR Part 814

    Administrative practice and procedure, Confidential business 
information, Medical devices, Medical research, Reporting and 
recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
814 is amended as follows:

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

    1.-The authority citation for 21 CFR part 814 continues to read as 
follows:

    Authority: Secs. 501, 502, 503, 510, 513-520, 701, 702, 703, 
704, 705, 708, 721, 801 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372, 373, 374, 375, 
379, 379e, 381).

    2.- Section 814.3 is amended by adding new paragraphs (k) and (l) 
to read as follows:


Sec. 814.3-  Definitions.

* * * * *
    (k) Reasonable probability means that it is more likely than not 
that an event will occur.
    (l) Serious, adverse health consequences means any significant 
adverse experience, including those which may be either life-
threatening or involve permanent or long term injuries, but excluding 
injuries that are nonlife-threatening and that are temporary and 
reasonably reversible.
    3. New Sec. 814.47 is added to subpart C to read as follows:


Sec. 814.47-  Temporary suspension of approval of a PMA.

    (a) Scope. (1) This section describes the procedures that FDA will 
follow in exercising its authority under section 515(e)(3) of the act 
(21 U.S.C. 360e(e)(3)). This authority applies to the original PMA, as 
well as any PMA supplement(s), for a medical device.
    (2) FDA will issue an order temporarily suspending approval of a 
PMA if FDA determines that there is a reasonable probability that 
continued distribution of the device would cause serious, adverse 
health consequences or death.
    (b) Regulatory hearing. (1) If FDA believes that there is a 
reasonable probability that the continued distribution of a device 
subject to an approved PMA would cause serious, adverse health 
consequences or death, FDA may initiate and conduct a regulatory 
hearing to determine whether to issue an order temporarily suspending 
approval of the PMA.
    (2) Any regulatory hearing to determine whether to issue an order 
temporarily suspending approval of a PMA shall be initiated and 
conducted by FDA pursuant to part 16 of this chapter. If FDA believes 
that immediate action to remove a dangerous device from the market is 
necessary to protect the public health, the agency may, in accordance 
with Sec. 16.60(h) of this chapter, waive, suspend, or modify any part 
16 procedure pursuant to Sec. 10.19 of this chapter.
    (3) FDA shall deem the PMA holder's failure to request a hearing 
within the timeframe specified by FDA in the notice of opportunity for 
hearing to be a waiver.
    (c) Temporary suspension order. If the PMA holder does not request 
a regulatory hearing or if, after the hearing, and after consideration 
of the administrative record of the hearing, FDA determines that there 
is a reasonable probability that the continued distribution of a device 
under an approved PMA would cause serious, adverse health consequences 
or death, the agency shall, under the authority of section 515(e)(3) of 
the act, issue an order to the PMA holder temporarily suspending 
approval of the PMA.
    (d) Permanent withdrawal of approval of the PMA. If FDA issues an 
order temporarily suspending approval of a PMA, the agency shall 
proceed expeditiously, but within 60 days, to hold a hearing on whether 
to permanently withdraw approval of the PMA in accordance with section 
515(e)(1) of the act and the procedures set out in Sec. 814.46.
    Dated: March 28, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-8361 Filed 4-4-96; 8:45 am]
BILLING CODE 4160-01-F