'Excellence' In Health-Software Design: US FDA Taps Nine Firms To Figure Out What That Means
• By David Filmore
The likes of Apple, Samsung and FitBit join traditional medtech players Johnson & Johnson and Roche, along with digital-health startups in a new US FDA pilot program intended to define best-practice software design as a means to "pre-certify" companies and reduce pre-market requirements. FDA's Bakul Patel and the CEO of one pilot participant, Pear Therapeutics, weighs in.
Engagement between FDA and the consumer tech world advanced Sept. 26 with the US agency's announcement of the participants selected for its nascent digital health "Pre-Cert" pilot program.
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