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'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.

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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.

Companies Selected For FDA Pre-Cert Pilot
  • Apple: iPhone/iPad/Apple Watch health apps could begin to venture into FDA regulation territory.
  • Fitbit: Leader in fitness wearables
  • Johnson & Johnson: Diversified medtech...

Apple, FitBit and Samsung were three of the nine companies chosen for the program, in which firms agree to interact with FDA and provide data to help establish certification standards...

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