# 21 C.F.R. § 860.210 (2026): De Novo request format

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P860_S860_210

## Section

- **Citation:** 21 C.F.R. § 860.210 (2026)
- **Heading:** De Novo request format
- **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 / § 860.210: § 860.210   De Novo request format.

## Text

(a) Each De Novo request or information related to a De Novo request pursuant to this part must be formatted in accordance with this section. Each De Novo request must be provided as a single version in electronic format. These materials must: (1)(i) For devices regulated by the Center for Devices and Radiological Health, be sent to the current address displayed on the website https://www.fda.gov/cdrhsubmissionaddress. (ii) For devices regulated by the Center for Biologics Evaluation and Research, be sent to the current address displayed on the website https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/regulatory-submissions-electronic-and-paper. (2) Be signed by the requester or an authorized representative. (3) Be designated “De Novo Request” in the cover letter. (4) Have all content used to support the request written in, or translated into, English.

## 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_210. Check the current official text before relying on it. Not legal advice.