Premarket review

The term is used in 21 CFR 3, where FDA assigns one center to lead the premarket review of a combination product, with consultation from other centers as needed.

Premarket review includes the examination of data and information in an application for premarket review described in sections 505, 510(k), 513(f), 515, or 520(g) or 520(l) of the act or section 351 of the Public Health Service Act of data and information contained in any investigational new drug (IND) application, investigational device exemption (IDE), new drug application (NDA), biologics license application, device premarket notification, device reclassification petition, and premarket approval application (PMA).

21 CFR, 3.2