The 510(k) Process — FDA Premarket Notification: Advanced
July 18, 2026 2026-07-20 16:30The 510(k) Process — FDA Premarket Notification: Advanced
The 510(k) Process: FDA Premarket Notification: Advanced
Develop the Refuse-To-Accept policy, 510(k) performance testing, Q-Submission (Pre-Sub) strategy and the Special, Abbreviated and Safety and Performance Based pathway variants.
Recommended prerequisite: completion of the Introductory level for this training, or relevant professional experience subject to Aleph University review.
Building on the substantial-equivalence and eSTAR foundation of the Introductory level, this Advanced course develops the acceptance, testing and agency-interaction disciplines that make a 510(k) succeed.
This 32-hour Professional Certificate Course covers the Refuse-To-Accept policy and checklist; performance-testing expectations (bench, biocompatibility, software, EMC); Q-Submission (Pre-Sub) interactions and strategy; and the Special and Abbreviated 510(k) variants and the Safety and Performance Based Pathway.
By the end, participants can evaluate a draft against the RTA checklist, draft a Q-Sub strategy memo and build a defensible 510(k) submission outline.
The Advanced course prepares participants to operate as a 510(k) author or reviewer at a manufacturer or regulatory consultancy, managing acceptance, testing and agency interactions.
Participants who meet the course completion requirements receive a Certificate of Completion issued by Aleph University.
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Professional development in medical devices, health technologies, regulatory affairs, and quality.
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