[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: 21CFR814.40]

[Page 139]
 
                        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. 814.40  Time frames for reviewing a PMA.


    Within 180 days after receipt of an application that is accepted for 
filing and to which the applicant does not submit a major amendment, FDA 
will review the PMA and, after receiving the report and recommendation 
of the appropriate FDA advisory committee, send the applicant an 
approval order under Sec. 814.44(d), an approvable letter under Sec. 
814.44(e), a not approvable letter under Sec. 814.44(f), or an order 
denying approval under Sec. 814.45. The approvable letter and the not 
approvable letter will provide an opportunity for the applicant to amend 
or withdraw the application, or to consider the letter to be a denial of 
approval of the PMA under Sec. 814.45 and to request administrative 
review under section 515 (d)(3) and (g) of the act.