Apple, Samsung, and Other Big Names in Tech Chosen for FDA ’s PreCert Pilot

FDA Commissioner Scott Gottlieb, MD told an audience Tuesday that nine firms—major tech companies among them—will take part in the new FDA Software Precertification (PreCert) Pilot Program. The companies were a select few plucked from a field of more than 100 applicants, and they have star power. Apple, Verily, Samsung, and Fitbit are just some of the well-known names. Other participants are Johnson & Johnson, Roche, New York’s Phosphorus, Palo Alto-based Tidepool, and Pear Therapeutics from Boston. “Our team will be spending the rest of the year working closely with these companies to deepen our understanding of their technologies and their operations and methodologies,” Gottlieb told attendees during his September 26 keynote speech at The Medtech Conference powered by AdvaMed. “This collaboration is a key part of establishing the proper regulatory framework.” As MD+DI previously reported, the pilot program, which is part of FDA’s Digital Health Innovation Action Plan, is intended to consider developer concerns, reduce regulatory burden, and determine metrics and quality standards that would qualify a company for precertification. The nine companies will open their facilities to FDA staff visits and will work with the agency to share how they build, assess, and maintain their software offerings, according to the press release. “We applaud the FDA for taking a progressive and thoughtful approach to designing a potential new digital health regulatory fram...
Source: MDDI - Category: Medical Devices Authors: Tags: Digital Health Source Type: news