Premarket Review Law and Legal Definition

Pursuant to 21 CFR 3.2 [Title 21 -- Food and Drugs; Chapter I -- Food and Drug Administration, Department of Health and Human Services], 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).”