---
kind: "section"
citation: "21 C.F.R. § 860.200"
title: "21"
number: "860.200"
heading: "Purpose and applicability."
url: "https://uscodex.org/cfr/21/860.200"
---

# §860.200. Purpose and applicability.

- (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)](/cfr/21/513.md?p=a-1) of the Federal Food, Drug, and Cosmetic Act and [§ 860.3](/cfr/21/860.3.md).
- (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.

## 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.