Navigating 510(k) & De Novo Requirements

AAMI's recurring 510(k) and De Novo course returns as a four-day virtual session, 3–6 November 2026, walking U.S. and global regulatory affairs leaders through both submission pathways — including the eSTAR template now required for 510(k) filings.

Dates and format

• Dates: 3–6 November 2026
• Schedule: four days, 9:00 a.m.–6:00 p.m. ET each day
• Format: virtual, live instruction via Zoom with direct interaction with instructors and other attendees
• Organizer: AAMI (Association for the Advancement of Medical Instrumentation)

What it covers

The course works through the elements and documentation a 510(k) submission requires, how to plan a device's design project around 510(k) clearance, and the De Novo pathway for devices without a predicate. With eSTAR submissions now required for 510(k)s, the course walks the eSTAR template section by section — alongside the broader run of recent 510(k) software and cybersecurity requirement changes, per AAMI's course description.

Who should attend

Regulatory affairs professionals preparing a 510(k) or De Novo submission, and quality or engineering leads who need to understand how a design project maps onto the clearance pathway they're targeting. AAMI runs this course periodically through the year, with a March 2026 offering already behind it and a March 2027 session already scheduled.

Working through the human-factors side of a device submission? AAMI's Human Factors for Medical Devices course runs the following month, and the full events directory lists everything we have verified.