{"data":{"id":"us/21-cfr-814.40","jurisdiction":"us","citation":"21 CFR 814.40","heading":"Time frames for reviewing a PMA.","body":"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)(4) and (g) of the act.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES","Subpart C—FDA Action on a PMA"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"f9771147443ae1a98a0aa6bca938cb3aa9e7b914ec3ef7831bccaca233fe5608","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-814.39","next":"us/21-cfr-814.42"},"notice":"GroundRules: Original legal text. Not legal advice."}