Faget Comments on New FDA Guidance

Special Counsel Kyle Faget  was quoted in a Mobi Health News article, “FDA releases revised draft guidance on CDS software, final guidelines on ‘device’ definitions for software such as wellness apps,” about new guidance designed to bring the agency’s efforts into compliance with provisions of the 21^st Century Cures Act.

Faget said regulatory uncertainty stifles innovation either by discouraging innovators from entering a field where the regulatory uncertainty creates an unnecessary barrier to entry or by delaying commercialization as innovators seek clarification regarding the regulatory status of their software. “Now that these guidances are available and in final form, digital health developers will have to get to work operationalizing the principles articulated in the guidances,” she said.