---
kind: "section"
citation: "21 C.F.R. § 814.114"
title: "21"
number: "814.114"
heading: "Timeframes for reviewing an HDE."
url: "https://uscodex.org/cfr/21/814.114"
---

# §814.114. Timeframes for reviewing an HDE.


Within 75 days after receipt of an HDE that is accepted for filing and to which the applicant does not submit a major amendment, FDA shall send the applicant an approval order, an approvable letter, a not approvable letter (under [§ 814.116](/cfr/21/814.116.md)), or an order denying approval (under [§ 814.118](/cfr/21/814.118.md)).


## Notes

### Amendments

[63 FR 59221, Nov. 3, 1998]

### Source

Source: 61 FR 33244, June 26, 1996, unless otherwise noted.

### 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

[63 FR 59221, Nov. 3, 1998]