[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR814.46]

[Page 129]
 
                        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. 814.46  Withdrawal of approval of a PMA.

    (a) FDA may issue an order withdrawing approval of a PMA if, from 
any information available to the agency, FDA determines that:
    (1) Any of the grounds under section 515(e)(1) (A)-(G) of the act 
applies.
    (2) Any postapproval requirement imposed by the PMA approval order 
or by regulation has not been met.
    (3) A nonclinical laboratory study that is described in the PMA and 
that is essential to show that the device is safe for use under the 
conditions prescribed, recommended, or suggested in its proposed 
labeling, was not conducted in compliance with the good laboratory 
practice regulations in part 58 and no reason for the noncompliance is 
provided or, if it is, the differences between the practices used in 
conducting the study and the good laboratory practice regulations do not 
support the validity of the study.
    (4) Any clinical investigation involving human subjects described in 
the PMA, subject to the institutional review board regulations in part 
56 or informed consent regulations in part 50, was not conducted in 
compliance with those regulations such that the rights or safety of 
human subjects were not adequately protected.
    (b)(1) FDA may seek advice on scientific matters from any 
appropriate FDA advisory committee in deciding whether to withdraw 
approval of a PMA.
    (2) FDA may use information other than that submitted by the 
applicant in deciding whether to withdraw approval of a PMA.
    (c) Before issuing an order withdrawing approval of a PMA, FDA will 
issue the holder of the approved application a notice of opportunity for 
an informal hearing under part 16.
    (d) If the applicant does not request a hearing or if after the part 
16 hearing is held the agency decides to proceed with the withdrawal, 
FDA will issue to the holder of the approved application an order 
withdrawing approval of the application. The order will be issued under 
Sec. 814.17, will state each ground for withdrawing approval, and will 
include a notice of an opportunity for administrative review under 
section 515(e)(2) of the act.
    (e) FDA will give the public notice of an order withdrawing approval 
of a PMA. The notice will be published in the Federal Register and will 
state that a detailed summary of information respecting the safety and 
effectiveness of the device, including information about any adverse 
effects of the device on health, has been placed on public display and 
that copies are available upon request. When a notice of withdrawal of 
approval is published, data and information in the PMA file will be 
available for public disclosure in accordance with Sec. 814.9.