Faget Comments on FDA Proposal to Streamline Premarket Review Submissions

Special Counsel Kyle Faget was quoted in a MobiHealthNews article, “Proposed framework lessens FDA’s regulatory requirements for prescription drugs companion apps,” about an FDA proposal that would classify most software released by pharmaceutical companies as “promotional labeling” not requiring premarket review.

Faget welcomed the proposed framework, but warned that any confusion regarding appropriate software classification could hamper the end goal of increased digital adoption.

“Sponsors wishing to enter this space will face several decision-points, including determining if the software application is a device subject to regulatory approval and whether the output of such software is FDA-required labeling or promotional labeling,” she said. “Confusion on any or all of these points may mean sponsors must avail themselves of FDA’s advisory comment process, which very well could have the contradictory effect of deterring software application innovation and use.”