# 21 C.F.R. § 860.200 (2026): Purpose and applicability

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P860_S860_200

## Section

- **Citation:** 21 C.F.R. § 860.200 (2026)
- **Heading:** Purpose and applicability
- **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 / § 860.200: § 860.200   Purpose and applicability.

## Text

(a) The purpose of this part is to establish an efficient, transparent, and thorough process to facilitate De Novo classification into class I or class II for devices for which there is no legally marketed device on which to base a review of substantial equivalence and which meet the definition of class I or class II as described in section 513(a)(1) of the Federal Food, Drug, and Cosmetic Act and § 860.3. (b) De Novo requests can be submitted for a single device type: (1) After receiving a not substantially equivalent determination in response to a premarket notification (510(k)), or (2) If a person determines there is no legally marketed device upon which to base a determination of substantial equivalence.

## 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_200. Check the current official text before relying on it. Not legal advice.