# 21 C.F.R. § 860.250 (2026): Withdrawal of a De Novo request

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P860_S860_250

## Section

- **Citation:** 21 C.F.R. § 860.250 (2026)
- **Heading:** Withdrawal of a De Novo request
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 21 CFR: Food and Drugs / Chapter I / Part 860 / Subpart D / § 860.250: § 860.250   Withdrawal of a De Novo request.

## Text

(a) FDA considers a De Novo request to have been withdrawn if: (1) The requester fails to provide a complete response to a request for additional information pursuant to § 860.240(b)(1) within 180 days after the date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) 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), 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to the De Novo request; or (4) The requester submits a written notice to FDA that the De Novo request has been withdrawn. (b) If a De Novo request is withdrawn, the Agency will notify the requester. The notice will include the De Novo request reference number and the date FDA considered the De Novo request withdrawn.

## Nearby sections

- [21 C.F.R. § 860.200 (2026) § 860.200   Purpose and applicability.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P860_S860_200.md)
- [21 C.F.R. § 860.210 (2026) § 860.210   De Novo request format.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P860_S860_210.md)
- [21 C.F.R. § 860.220 (2026) § 860.220   De Novo request content.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P860_S860_220.md)
- [21 C.F.R. § 860.230 (2026) § 860.230   Accepting a De Novo request.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P860_S860_230.md)
- [21 C.F.R. § 860.240 (2026) § 860.240   Procedures for review of a De Novo request.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P860_S860_240.md)
- [21 C.F.R. § 860.250 (2026) § 860.250   Withdrawal of a De Novo request.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P860_S860_250.md)
- [21 C.F.R. § 860.260 (2026) § 860.260   Granting or declining a De Novo request.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P860_S860_260.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P860_S860_250. Check the current official text before relying on it. Not legal advice.