CPC Comments on FDA’s Draft Guidance “Content of Premarket Submissions for Device Software Functions”

On February 1, 2022, the CPC submitted a letter to FDA regarding the agency’s recent draft guidance on the “Content of Premarket Submissions for Device Software Functions.” Overall, CPC supports further development of guidance on this topic, but would appreciate additional clarity in the final guidance regarding CPC’s comments concerning cross-Center adoption of the software review policies on software documentation and application of the guidance to NDA and IND applications.