[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: 21CFR814.42]

[Page 125-126]
 
                        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. 814.42  Filing a PMA.

    (a) The filing of an application means that FDA has made a threshold 
determination that the application is sufficiently complete to permit a 
substantive review. Within 45 days after a PMA is received by FDA, the 
agency will notify the applicant whether the application has been filed.
    (b) If FDA does not find that any of the reasons in paragraph (e) of 
this section for refusing to file the PMA applies, the agency will file 
the PMA and will notify the applicant in writing of the filing. The 
notice will include the PMA reference number and the date FDA filed the 
PMA. The date of filing is the date that a PMA accepted for filing was 
received by the agency. The 180-day period for review of a PMA starts on 
the date of filing.
    (c) If FDA refuses to file a PMA, the agency will notify the 
applicant of the reasons for the refusal. This notice will identify the 
deficiencies in the application that prevent filing and will include the 
PMA reference number.
    (d) If FDA refuses to file the PMA, the applicant may:
    (1) Resubmit the PMA with additional information necessary to comply

[[Page 126]]

with the requirements of section 515(c)(1) (A)-(G) of the act and 
Sec. 814.20. A resubmitted PMA shall include the PMA reference number of 
the original submission. If the resubmitted PMA is accepted for filing, 
the date of filing is the date FDA receives the resubmission;
    (2) Request in writing within 10 working days of the date of receipt 
of the notice refusing to file the PMA, an informal conference with the 
Director of the Office of Device Evaluation to review FDA's decision not 
to file the PMA. FDA will hold the informal conference within 10 working 
days of its receipt of the request and will render its decision on 
filing within 5 working days after the informal conference. If, after 
the informal conference, FDA accepts the PMA for filing, the date of 
filing will be the date of the decision to accept the PMA for filing. If 
FDA does not reverse its decision not to file the PMA, the applicant may 
request reconsideration of the decision from the Director of the Center 
for Devices and Radiological Health. The Director's decision will 
constitute final administrative action for the purpose of judicial 
review.
    (e) FDA may refuse to file a PMA if any of the following applies:
    (1) The application is incomplete because it does not on its face 
contain all the information required under section 515(c)(1) (A)-(G) of 
the act;
    (2) The PMA does not contain each of the items required under 
Sec. 814.20 and justification for omission of any item is inadequate;
    (3) The applicant has a pending premarket notification under section 
510(k) of the act with respect to the same device, and FDA has not 
determined whether the device falls within the scope of Sec. 814.1(c).
    (4) The PMA contains a false statement of material fact.
    (5) The PMA is not accompanied by a statement of either 
certification or disclosure as required by part 54 of this chapter.

[51 FR 26364, July 22, 1986, as amended at 63 FR 5254, Feb. 2, 1998]