FDA Readies Digital Health Pre-Cert Program For Lift Off

26 Apr 2018

• By David Filmore

US FDA laid out its proposed starting model to launch the pre-certification program for digital health products, including a matrix for when pre-certified app and software developers could bring new or modified products to market with either streamlined or no pre-market review.

airport runway under the sun as background

Even the highest-risk apps, based on patient condition and significance of information, would be allowed to take advantage of a streamlined review process for companies vetted under US FDA's oncoming pre-certification program under an initial outline of the program. And many lower-risk apps would see no review to reach market. That's according to the agency's newly posted "working model" for the pre-cert program, which the agency plans to launch in its first iteration by the end of the year.

FDA has been developing the model since last summer in a pilot project that involved close collaboration with nine device...