No medical device reaches the market without crossing the essential U.S. FDA jurisdiction. A regulatory-affairs professional must move fluently through the FFDCA (§510, 513, 515) and the organization of 21 CFR: Part 807 for 510(k), Part 814 for PMA, Part 812 for IDE.

This 16-hour Professional Certificate Course introduces the FDA framework across the device life cycle, device classification (Class I/II/III), the submission pathways (510(k), De Novo, PMA, HDE) and their selection, and IDE clinical investigations.

The Introductory course prepares participants for the Advanced level (RAQ-620-A), where EU MDR conformity assessment, QMSR quality-system compliance, post-market surveillance and the emerging regulatory frameworks are developed in depth.

The Introductory course gives regulatory, quality and engineering professionals the FDA classification and submission-pathway foundation on which every U.S. market-access strategy depends.

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