21 CFR 814.40
§ 814.40 Time frames for reviewing a PMA.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 814.40, § 814.40 Time frames for reviewing a PMA, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88863
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.