---
kind: "section"
citation: "21 C.F.R. § 860.250"
title: "21"
number: "860.250"
heading: "Withdrawal of a De Novo request."
url: "https://uscodex.org/cfr/21/860.250"
---

# §860.250. Withdrawal of a De Novo request.

- (a) **FDA considers a De Novo request to have been withdrawn if—**
  - (1) The requester fails to provide a complete response to a request for additional information pursuant to [§ 860.240(b)(1)](/cfr/21/860.240.md?p=b-1) within 180 days after the date FDA issues such request;
  - (2) The requester fails to provide a complete response to the deficiencies identified by FDA pursuant to [§ 860.230(c)(2)](/cfr/21/860.230.md?p=c-2) within 180 days of the date notification was issued by FDA;
  - (3) The requester does not permit an authorized FDA employee an opportunity to inspect the facilities, pursuant to [§ 860.240(c)](/cfr/21/860.240.md?p=c), at a reasonable time and in a reasonable manner, and to have access to copy and verify all records pertinent to the De Novo request; or
  - (4) **The requester submits a written notice to FDA that the De Novo request has been withdrawn.**
- (b) If a De Novo request is withdrawn, the Agency will notify the requester. The notice will include the De Novo request reference number and the date FDA considered the De Novo request withdrawn.

## Notes

### Source

Source: 86 FR 54847, Oct. 5, 2021, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 321(h), 353(g), 360c, 360d, 360e, 360i, 360j, 371, 374.

### Source

Source: 43 FR 32993, July 28, 1978, unless otherwise noted.