21 C.F.R. § 860.200

Current through October 31, 2024
Section 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) 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.

21 C.F.R. §860.200

86 FR 54826 , 1/3/2022