Supplemental Application [Food and Drugs] Law and Legal Definition

Pursuant to 21 CFR 99.3 (k) [Title 21 Food and Drugs; Chapter I Food and Drug Administration, Department of Health and Human Services; Subchapter A General; Part 99 Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices; Subpart A General Information], Supplemental Application means:

“(1) For drugs, a supplement to support a new use to an approved new drug application;

(2) For biologics, a supplement to an approved license application;

(3) For devices that are the subject of a cleared 510(k) submission and devices that are exempt from the 510(k) process, a new 510(k) submission to support a new use or, for devices that are the subject of an approved premarket approval application, a supplement to support a new use to an approved premarket approval application.”