Digital health, including mobile apps, machine learning, artificial intelligence and wearables, are in the mainstream and the health-regulated industry is adapting to integrate these technological advances into medical devices and drugs. The Food Drug and Law Institute is hosting a 2-day event in the Bay Area with guest speakers from FDA and industry in discussing the regulatory pathway of digital health and FDA's recent initiatives in adapting this technology through the 21st Century Cures Act, 510(k) reform, the Office of Combination Products, and the Software Precertification Pilot Program (Pre-Cert).
I will be attending the event. Please say hi. Details of the event is as follows:
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