US FDA update on new pathway for digital health innovations

US Food and Drug Administration Commissioner Scott Gottlieb has provided an update on the agency’s new actions under the Digital Health Precertification (Pre-Cert) Program.

The agency previously announced that it would implement the program, as part of the Digital Health Innovation Action Plan. The purpose is to promote a more efficient framework to review digital health innovations.

Following a pilot of the Pre-Cert program, Dr Gottlieb says the FDA has now drafted a regulatory framework to test new approaches for reviewing such innovations.