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.
21 CFR Part 814 · Premarket Approval of Medical Devices
§ 814.40 Time frames for reviewing a PMA
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
FDA guidance that cites § 814.40
- Premarket Approval Application and Humanitarian Device Exemption Modular Review: Guidance for Industry and FDA Staff 13 Jan 2025
- Humanitarian Device Exemption (HDE) Program: Guidance for Industry and Food and Drug Administration Staff 6 Sept 2019
Amendment history
Federal Register documents that created or amended this section.
- 51 FR 26364 22 Jul 1986
- 87 FR 2045 13 Jan 2022