Faget Comments on Updates to FDA’s Pre-Cert Program

08 January 2019 MobiHealthNews News

Special Counsel Kyle Faget was quoted in a MobiHealthNews article, “FDA looks to De Novo pathway model as it unveils updates to Pre-Cert program,” about the FDA’s unveiling of new updates to its Digital Health Precertification (Pre-Cert) program.

Faget said the changes are a “welcomed move” toward giving teeth to the program. “Having a clear regulatory framework for testing new approaches for the review of digital health device applications, engaging in a test plan to assess how the program can maintain standards for assuring safe and effective products, and releasing a working model that incorporates the regulatory framework and the test plan aimed at establishing the components FDA envisions for the future of the Pre-Certification program is evidence that the FDA is committed to supporting the efficient review and ultimate commercialization of digital technologies,” she said.

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