The agency’s Pre-Cert for Software Pilot Program — part of the FDA’s Digital Health Innovation Action Plan — will streamline FDA approvals for digital health technologies by reviewing developers rather than their individual products.
“We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices,” Dr. Gottlieb said.
To participate in the pilot program participants must provide the FDA insights on how they develop, test and maintain their software products, as well as how they collect post-market data.
Here are the nine FDA pre-certified digital health companies, listed in alphabetical order.
1. Cupertino, Calif.-based Apple
2. San Francisco-based Fitbit
3. New Brunswick, N.J.- based Johnson & Johnson
4. Boston-based Pear Therapeutics
5. New York City-based Phosphorus
6. Basel, Switzerland-based Roche
7. Seoul, South Korea-based Samsung
8. Palo Alto, Calif.-based Tidepool
9. Mountain View, Calif.-based Verily
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