How Much Evidence Will FDA Expect?

For an early-stage medical device company, one of the most important - and potentially expensive - questions is: How much evidence will FDA actually expect?

The answer can affect development timelines, testing budgets, fundraising needs, and ultimately the regulatory pathway to market.

This free virtual educational session is designed for medical device founders, startup executives, and early-stage product teams that are planning testing, already generating verification and validation evidence, or beginning to think about an FDA submission.

During this practical session, we'll discuss how factors such as intended use, device classification, regulatory pathway, predicate strategy, technological differences, product claims, and device risk can influence the amount and type of evidence a company may need.

The formal presentation will be kept short so there is time for live Q&A and discussion of common regulatory challenges facing early-stage MedTech companies.

Speaker: Mirna Hassoun, Founder and Principal Consultant at Strata Regulatory, an Orange County medical device regulatory consulting firm.

This program is educational and does not provide company-specific regulatory or legal advice.

Free | Virtual | October 8, 2026 | 12:00–12:45 PM Pacific