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FDA Readies Digital Health Pre-Cert Program For Lift Off

 
• 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 and consumer tech companies. (Also see "Coming Together On Pre-Cert: Digital Health World Engages With FDA To Hash Out Regulatory Future" - Medtech Insight, 6 February, 2018.) Now the agency says it is ready to make the first version, "Pre-Cert 1.0," a reality, though it will be updated often

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