---
kind: "section"
citation: "21 C.F.R. § 814.40"
title: "21"
number: "814.40"
heading: "Time frames for reviewing a PMA."
url: "https://uscodex.org/cfr/21/814.40"
---

# §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)](/cfr/21/814.44.md?p=d), an approvable letter under [§ 814.44(e)](/cfr/21/814.44.md?p=e), a not approvable letter under [§ 814.44(f)](/cfr/21/814.44.md?p=f), or an order denying approval under [§ 814.45](/cfr/21/814.45.md). 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](/cfr/21/814.45.md) and to request administrative review under section [515 (d)(4)](/cfr/21/515.md?p=d-4) and [(g)](/cfr/21/515.md?p=d-g) of the act.


## Notes

### Amendments

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

### Authority

Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b, 371, 372, 373, 374, 375, 379, 379e, 379k-1, 381.

### Source

Source: 51 FR 26364, July 22, 1986, unless otherwise noted.

### Amendments

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