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FDA Pitches Novel Pathway For Software

In this video from the inaugural Digital Medtech Conference, in San Francisco, FDA's Bakul Patel discusses the agency's thinking behind a proposed "FDA Precheck" program to expedite the path to market for "software as a medical device" products, and industry players respond.

On March 2, Bakul Patel, FDA associate director for digital health, presented a proposal for an "FDA Precheck" expedited review pathway for software as a medical device (SAMD) products. While it is an early-stage concept, Patel urged attendees at AdvaMed's inaugural Digital Medtech Conference in San Francisco to provide feedback.

Following his talk, Patel was joined by Ashwin Pushpala, founder of glucose-monitor app start-up Sano; Larry Carrier, head of regulatory affairs at Verily Life Sciences LLC; and Nathan Brown,...

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