§860.200. Purpose and applicability.
21 C.F.R. § 860.200
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.
De Novo requests can be submitted for a single device type—
After receiving a not substantially equivalent determination in response to a premarket notification (510(k)), or
If a person determines there is no legally marketed device upon which to base a determination of substantial equivalence.
Notes, amendments, and revision history
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.