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US FDA Looks To Add More Players To Digital Pre-Cert Pilot, And Launch Program

The agency's associate director for digital health said the agency will expand its digital health pre-certification pilot program to get more input before the year's end. The agency hopes to launch an initial program based on the pilot by years end.

US FDA plans to open its closely watched digital-health pre-certification pilot program to more companies before the end of the year. The agency is also trying to aggregate as much feedback and information as possible before it hopes to launch a program late this year based on the ongoing pilot to create a faster pathway to market for developers of software as medical devices.

Speaking to industry stakeholders at the Association for the Advancement for Medical Instrumentation’s (AAMI) conference in Virginia, Bakul Patel, FDA associate director for digital health, said the pilot project that started with nine companies will continue and add more before

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