[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR814.45]

[Page 141-142]
 
                        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. 814.45  Denial of approval of a PMA.

    (a) FDA may issue an order denying approval of a PMA if the 
applicant fails to follow the requirements of this part or if, upon the 
basis of the information submitted in the PMA or any other information 
before the agency, FDA determines that any of the grounds for denying 
approval of a PMA specified in section 515(d)(2) (A)-(E) of the act 
applies. In addition, FDA may deny approval of a PMA for any of the 
following reasons:
    (1) The PMA contains a false statement of material fact;
    (2) The device's proposed labeling does not comply with the 
requirements in part 801 or part 809;

[[Page 142]]

    (3) The applicant does not permit an authorized FDA employee an 
opportunity to inspect at a reasonable time and in a reasonable manner 
the facilities, controls, and to have access to and to copy and verify 
all records pertinent to the application;
    (4) 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; or
    (5) 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) FDA will issue any order denying approval of the PMA in 
accordance with Sec. 814.17. The order will inform the applicant of the 
deficiencies in the PMA, including each applicable ground for denial 
under section 515(d)(2) of the act and the regulations under this part, 
and, where practical, will identify measures required to place the PMA 
in approvable form. The order will include a notice of an opportunity to 
request review under section 515(d)(3) of the act.
    (c) FDA will use the criteria specified in Sec. 860.7 to determine 
the safety and effectiveness of a device in deciding whether to approve 
or deny approval of a PMA. FDA may use information other than that 
submitted by the applicant in making such determination.
    (d)(1) FDA will give the public notice of an order denying approval 
of the PMA. The notice will be placed on the FDA's home page on the 
Internet (http://www.fda.gov), and it 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, 
is available on the Internet and has been placed on public display and 
that copies are available upon request. FDA will publish in the Federal 
Register after each quarter a list of the denials announced in that 
quarter. When a notice of denial of approval is made publicly available, 
data and information in the PMA file will be available for public 
disclosure in accordance with Sec. 814.9.
    (2) A request for copies of the current PMA approvals and denials 
document and copies of summaries of safety and effectiveness shall be 
sent in writing to the Freedom of Information Staff (HFI-35), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
    (e) FDA will issue an order denying approval of a PMA after an 
approvable or not approvable letter has been sent and the applicant:
    (1) Submits a requested amendment but any ground for denying 
approval of the application under section 515(d)(2) of the act still 
applies; or
    (2) Notifies FDA in writing that the requested amendment will not be 
submitted; or
    (3) Petitions for review under section 515(d)(3) of the act by 
filing a petition in the form of a petition for reconsideration under 
Sec. 10.33.

[51 FR 26364, July 22, 1986, as amended at 63 FR 4572, Jan. 30, 1998]