US FDA Collecting Feedback On Digital Health Plan

FDA's commissioner has signaled plans to pilot a new approach to digital health oversight, but the agency cautions that it is still putting the program together based, in part, on feedback from stakeholders. More details will be released by the time a pilot program launches in the fall.

While US FDA has not solidified details of a new digital health pilot pitched by Commissioner Scott Gottlieb, the agency is collecting feedback from industry, and so far the response has been positive, according to a spokeswoman.

On June 15, Commissioner Gottlieb penned an FDA blog post about a new plan to not only enact digital health provisions mandated under the 21st Century Cures Act...

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