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FDA's Bakul Patel Discusses Pre-Cert Program Working Model

In a Medtech Insight exclusive podcast interview, US FDA's Bakul Patel talks about what the agency wants to learn from a newly released "working model" intended to set the initial foundations for the digital health pre-certification program. The first version of the program will start before year's end and he's hoping for industry feedback to prepare for it.

Exclusive interview Q&A KOI

It was a active day for digital health announcements at US FDA April 26. (Also see "Gottlieb Unveils Next Steps In Digital Health Plan" - Medtech Insight, 26 April, 2018.) One new announcement from Commissioner Scott Gottlieb that day was a newly issued "working model" for the agency's nascent pre-certification program. (Also see "FDA Readies Digital Health Pre-Cert Program For Lift Off" - Medtech Insight, 26 April, 2018.) Soon after that was released, Medtech Insight spoke to Bakul Patel, associate director of digital health at FDA, about the plan.

The working model outlines some proposed details of how the program could run, including in what instances companies that are pre-certified can benefit from streamlined or no pre-market review for...

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