[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR814.47]

[Page 129-130]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES--Table of Contents
 
                     Subpart C--FDA Action on a PMA
 
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 
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[[Page 130]]

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.

[61 FR 15190, Apr. 5, 1996]

Subpart D--Administrative Review [Reserved]