[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: 21CFR814.37]

[Page 137]
 
                        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 B_Premarket Approval Application (PMA)
 
Sec. 814.37  PMA amendments and resubmitted PMA's.

    (a) An applicant may amend a pending PMA or PMA supplement to revise 
existing information or provide additional information.
    (b) FDA may request the applicant to amend a PMA or PMA supplement 
with any information regarding the device that is necessary for FDA or 
the appropriate advisory committee to complete the review of the PMA or 
PMA supplement.
    (c) A PMA amendment submitted to FDA shall include the PMA or PMA 
supplement number assigned to the original submission and, if submitted 
on the applicant's own initiative, the reason for submitting the 
amendment. FDA may extend the time required for its review of the PMA, 
or PMA supplement, as follows:
    (1) If the applicant on its own initiative or at FDA's request 
submits a major PMA amendment (e.g., an amendment that contains 
significant new data from a previously unreported study, significant 
updated data from a previously reported study, detailed new analyses of 
previously submitted data, or significant required information 
previously omitted), the review period may be extended up to 180 days.
    (2) If an applicant declines to submit a major amendment requested 
by FDA, the review period may be extended for the number of days that 
elapse between the date of such request and the date that FDA receives 
the written response declining to submit the requested amendment.
    (d) An applicant may on its own initiative withdraw a PMA or PMA 
supplement. If FDA requests an applicant to submit a PMA amendment and a 
written response to FDA's request is not received within 180 days of the 
date of the request, FDA will consider the pending PMA or PMA supplement 
to be withdrawn voluntarily by the applicant.
    (e) An applicant may resubmit a PMA or PMA supplement after 
withdrawing it or after it is considered withdrawn under paragraph (d) 
of this section, or after FDA has refused to accept it for filing, or 
has denied approval of the PMA or PMA supplement. A resubmitted PMA or 
PMA supplement shall comply with the requirements of Sec. 814.20 or 
Sec. 814.39, respectively, and shall include the PMA number assigned to 
the original submission and the applicant's reasons for resubmission of 
the PMA or PMA supplement.