§ 860.200. Purpose and applicability.
120 words·~1 min read·
/us/cfr/t21/s§ 860.200·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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.