CDS Coalition Submits Comments on FDA’s Clinical and Patient Decision Support Software Draft Guidance

On February 5, 2018, the Coalition submitted comments to Docket No. FDA-2017-D-6569, “Clinical and Patient Decision Support Software: Draft Guidance for Industry and FDA Staff.” The comments voice the Coalition’s concern that the Draft Guidance would substantially expand the scope of FDA regulation of CDS software because (1) it fails to take a risk-based approach, and (2) it would extend regulation to any software that offers insights that the user might not be expected to come up with on his or her own.

We recommend various revisions to the Draft Guidance, including incorporation of the IMDRF criteria for stratifying risk of CDS software, and allowing for the possibility of unregulated software that provides unique insights that the healthcare professional might not have come up with on his or her own (as long as the user has access to the factual basis for the insights).

Download the documents (PDF):
FINAL-CDS-Coalition-Comments-to-CDS-Software-Draft-Guidance-5Feb2018.pdf
Appendix-B-to-CDS-Draft-Guidance-Comment-Letter-CDS-3060-Guidelines-Final.pdf