21 CFR § 814.40 - Time frames for reviewing a PMA.

---
identifier: "/us/cfr/t21/s814.40"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 814.40 - Time frames for reviewing a PMA."
title_number: 21
title_name: "Food and Drugs"
section_number: "814.40"
section_name: "Time frames for reviewing a PMA."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "814"
part_name: "PREMARKET APPROVAL OF MEDICAL DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b, 371, 372, 373, 374, 375, 379, 379e, 379k-1, 381."
regulatory_source: "51 FR 26364, July 22, 1986, unless otherwise noted."
cfr_part: "814"
---


# 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 § 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.

[51 FR 26364, July 22, 1986, as amended at 87 FR 2045, Jan. 13, 2022]