Most medical devices reaching the U.S. market do so through the 510(k) pathway: Premarket Notification under FFDCA §510(k) and 21 CFR Part 807 Subpart E. A regulatory-affairs professional building a career in devices must master every piece of the process.

This 16-hour Professional Certificate Course introduces the legal authority of the 510(k), 21 CFR Part 807 Subpart E, the reasoning of substantial equivalence anchored in FDA’s July 2014 guidance and real Decision Summaries, predicate research in the FDA 510(k) database, and the structure of the submission in the eSTAR format.

The Introductory course prepares participants for the Advanced level (RAQ-630-A), where the Refuse-To-Accept policy, performance testing, Q-Submission strategy and the 510(k) variants are developed in depth.

The Introductory course gives regulatory professionals the substantial-equivalence and predicate foundation on which every 510(k) submission and review depends.

Participants who meet the course completion requirements receive a Certificate of Completion issued by Aleph University.