Digital health is increasingly central to the overall medtech story, and FDA has placed a major emphasis on refining its approaches to meet the needs of this evolving space. In this panel discussion from the MedTech Strategist Innovation Summit San Francisco 2021 that took November 3, two regulatory affairs experts talk about FDA’s efforts. Yarmela Pavlovic, VP of regulatory strategy at Medtronic, and Ankur Kaushal, VP of Regulatory Affairs and Quality at Big Health, digital therapeutics company, discuss the agency’s special allowances for digital tools during the pandemic and how FDA may transition these policies as we eventually move beyond the public health emergency. The experts also offer insights on real-world evidence, the Precertification Program, AI/ML regulatory strategies, and the FDA experience seen through the eyes of start-ups versus big medtech. The discussion was moderated by David Filmore, Executive Editor of Market Pathways.

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