On December 13, 2019, the CDS Coalition submitted comments on FDA’s Reproposed “Clinical Decision Support Software: Draft Guidance for Industry and FDA Staff,” which was originally proposed on December 8, 2017. While the CDS Coalition appreciates that this reproposed CDS guidance draft moves toward a risk-based approach, we believe it does not go far enough. In particular, the agency should: (i) exclude more software as low risk; (ii) not try to limit the scope of the Cures Act’s transparency exclusion to only software which, in the IMDRF terminology, merely informs or provides options regarding clinical management of patients; and (iii) not limit its enforcement discretion to only patient-directed software that informs clinical management for non-serious situations or conditions.

Download the comments in PDF format.

The Coalition compliments FDA on both its vision for a better, more effective regulatory approach for software as a medical device (“SaMD”), as well as the Agency’s approach of periodically putting drafts of the working model out for public comment.  Further, and as stated in our prior comments, the Coalition believes this is an incredibly important initiative that the Agency is undertaking. However, we offer comments on five different topics:

1. How does the precertification program address low risk and ultra-low risk products?
2. The need to include software used with drugs.
3. Missing programmatic elements.
4. What is FDA’s claimed legal authority for conducting the pilot program in 2019 and for implementing the program thereafter?
5. The staffing challenges of regulating corporate entities and their cultures, as compared to evaluating the safety and effectiveness of a device.

Download the comments in PDF format.

In response to FDA’s May 29, 2018 request for input, on June 21, 2018, the CDS Coalition provided feedback on the benefits and risks to health associated with the medical software functions excluded from the FDCA “device” definition by the 21st Century Cures Act. Specifically, the Coalition offered information on: (1) the benefits of CDS software; and (2) industry’s efforts to develop and implement guidelines that identify appropriate disclosures designed to promote “safety, education and competency” related to CDS software unregulated by FDA.

Download the PDF.

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2018, the Coalition submitted comments to Docket No. FDA-2017-D-6569, “Clinical and Patient Decision Support Software: Draft Guidance for Industry and FDA Staff.”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

On September 29, 2017, the Coalition provided comments to FDA’s Digital Health Innovation Action Plan docket. The comments applaud the release of the Action Plan, and highlight the importance of increased FDA attention and focus on machine learning. Specifically, the Coalition suggests that FDA consider participating in a mock presubmission meeting to improve understanding of issues that arise in submissions that include machine learning intended for CDS software.

Download in PDF format.

On September 5, 2017, the Coalition submitted comments to Docket No. FDA-2017-N-4301, “Fostering Medical Innovation: A Plan for Digital Health Devices; Software Precertification Pilot Program.” The comments recommend that FDA consider providing additional avenues for stakeholder involvement in the pilot program, for example, by preparing regular public blog posts about the program.

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The CDS Coalition has developed the attached voluntary guidelines for use by clinical decision support, or CDS, software developers to guide the design of such software. The purpose of these guidelines is to ensure that software, as much as possible, leaves the user firmly in control of the clinical decision-making. As explained more in the guidelines themselves, we have been also influenced by some recent legislation that articulates the dividing line between FDA regulation and the practice of medicine.

The coalition is comprised of large and small software developers, including those traditionally from the medical space as well as those new to the area. The coalition also includes hospitals and other users of such software, as well as those who make pharmaceutical products and medical devices that are guided by the software. But we recognize that there is a vast universe of organizations out there impacted by CDS, and so we would like to solicit comments from all those affected.

Our plan is to collect comments through July 1, 2017, and then make appropriate revisions. After that, we plan to present these guidelines to FDA for their feedback.

If you have any questions or concerns, please let me know. Please direct your comments to me, Brad Thompson, at bthompson@EBGlaw.com.

We would very much appreciate hearing your thoughts.

Download the Guidelines in PDF format.

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.

Download the Clinical Eval Comments (PDF)

Download the Feb. 17 Comment from CDS Coalition (PDF)