CDS Coalition Submits Comments on FDA’s “Draft Guidance for Software as a Medical Device: Clinical Evaluation”
On December 9, 2016, the Coalition submitted comments on FDA’s SaMD Clinical Evaluation Draft Guidance, which communicate concern about the proposed standards for clinical evaluation of medical software being more demanding than what FDA has historically required. The comments also voice administrative concerns about the draft guidance, including lack of clarity regarding the scope of what the Agency plans to adopt, and lack of linkage between the draft guidance and current US laws, regulations, and policy. Note that following discussion with FDA regarding the process behind the development of the draft guidance, the Coalition submitted a follow-up letter to its original comments.