US FDA launches Digital Health Innovation Action Plan & Pre-Certification Software Pilot Program

Last week, the US Food & Drug Administration unveiled its Digital Health Innovation Action Plan.

As one part of the plan, the FDA is launching a Software Pre-Certification Pilot Program to facilitate faster market access for digital health products via assessment of companies that perform high-quality software design and testing.

The pilot launches on September 1, 2017 and statements of interest can be submitted starting August 1, 2017.

To get more details on the pilot program, click here.

To read the Digital Health Innovation Action Plan in PDF form, click here.