FDA is looking for new companies to test out its pre-cert pilot program
The regulator is opening up the program to 510(k) submissions, instead of its initial focus on companies moving through the De Novo regulatory pathway.
Insights from the FDA’s digital health lead Bakul Patel at MedCity INVEST
At the MedCity INVEST Conference in Chicago, the FDA's Bakul Patel spoke about the recent developments in the agency's thinking about regulating the emerging Software as a Medical Device space.
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Check out the speaker lineup for MedCity INVEST
MedCity INVEST is coming up next month. We've lined up a fantastic group of speakers for the two day conference in Chicago at the Ritz Carlton April 23-24 such as former Cleveland Clinic CEO Dr. Toby Cosgrove, Wellville Founder Esther Dyson, Bakul Patel of the FDA and more!
Amidst plans to expand FDA digital health pre-certification pilot program, concerns about its future
Bakul Patel — digital health director at CDRH — acknowledged that the group is still figuring out how the pre-certification program should look.