[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: 21CFR814.40]

[Page 125]
 
                        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.