Premarket Review

**Semantic type:** Activity

**Definition:** 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 Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act of data and information contained in any investigational new drug application, investigational device exemption, new drug application, biologics license application, device premarket notification, device reclassification petition, and premarket approval application.