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Coming Together On Pre-Cert: Digital Health World Engages With FDA To Hash Out Regulatory Future

US FDA, industry and other digital health stakeholders huddled at the National Institutes of Health for two days of deep discussions around how the Pre-Certification Pilot was advancing, and how the agency should implement a program that emphasizes certifying "excellence" in company processes. Check out coverage of the meeting and Medtech Insight's exclusive podcast interview with FDA project lead Bakul Patel.

hands in
Pear Therapeutics' David Amor and FDA's Marisa Cruz lead a team huddle after a breakout session at FDA's Pre-Cert workshop. • Source: Ferdous Al-Faruque

Over the past few months, US FDA representatives have made a series of site visits to companies, looking to unearth in-depth details of how the firms operate. But, by all accounts, the atmosphere of the visits wasn't adversarial or tense; it was collaborative.

The reason? The visits were not inspections but company-hosted fact-finding missions, designed to help the agency formulate a regulatory approach centered around evaluating a company's design and development processes more...

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