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.
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.
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.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
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!
Bakul Patel — digital health director at CDRH — acknowledged that the group is still figuring out how the pre-certification program should look.