21 C.F.R. § 814.40 Time frames for reviewing a PMA.
Title 21 - Food and Drugs
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 §814.44(d), an approvable letter under §814.44(e), a not approvable letter under §814.44(f), or an order denying approval under §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 §814.45 and to request administrative review under section 515 (d)(3) and (g) of the act.
Title 21: Food and Drugs
PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES
Subpart C—FDA Action on a PMA
§ 814.40 Time frames for reviewing a PMA.
