Bloomberg Law
June 27, 2019, 9:39 PM

Next Phase of Digital Device Pilot Coming From FDA This Summer

Ayanna Alexander
Ayanna Alexander

The FDA’s latest plans to balance cybersecurity and effectiveness for digital health devices will come out this summer as part of the next phase of its early review pilot program.

“We have promised and we do intend to release an update mid-year, which I do expect will be somewhat soon during the summer timeframe, and that’s where we’ll speak more about what we’re finding,” Matthew Diamond, a digital health official for the agency, said during a June 27 telehealth event. “But we are already conducting this investigation with real companies and real products.”

The Food and Drug Administration has been ...