On February 6, 2023, the CDS Coalition filed a citizens petition at the U.S. Food and Drug Administration in response to FDA’s publication of the Final Guidance on Clinical Decision Support Software on September 28, 2022. The Petition requested that the FDA Commissioner rescind the final CDS Guidance and repropose the guidance to align with the statutory language, as explained in the petition.
Download the petition in PDF format.
On December 13, 2019, the CDS Coalition submitted comments on FDA’s Reproposed “Clinical Decision Support Software: Draft Guidance for Industry and FDA Staff,” which was originally proposed on December 8, 2017.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.
See Below to Download Materials from the July 11 Encore Lecture
Much is changing with regard to how the U.S. Food and Drug Administration (FDA) approaches software generally, and artificial intelligence in particular. Some of that change is driven by the remarkable innovation going on right now at universities and in industry. But some of the change originates with the government.
For example:
- In December 2016, Congress enacted the 21st Century Cures Act, which fundamentally changed the scope of FDA regulation of clinical decision support software.
- In December 2017, FDA published a draft guidance building on that legislation, providing the agency’s perspective on the clinical decision support software that FDA should regulate and what it should not. That guidance has profound implications for artificial intelligence used to guide healthcare decision-making.
- Throughout 2018, FDA will be engaging in a year-long process of completely revamping the agency’s approach to regulating software. FDA calls its new program the “Precertification Program.”
Bradley Merrill Thompson (Chairman of the Board of consulting firm EBG Advisors) and Scott Thiel (Director of Navigant Consulting) will discuss FDA regulation of artificial intelligence in healthcare and methods the FDA uses to regulate devices that include artificial intelligence. This webinar highlights presentations on the same topic from the highly successful in-person roadshow held at eight major engineering schools around the country.
We understand you may have missed the opportunity to join us in-person at the roadshow. Therefore, please join us for this last lecture of the Startup Roadshow – AI in Healthcare. We look forward to you attending this encore webinar!
For more information on the agenda, click here.
Who Should Attend
The webinar is focused on entrepreneurs and experienced developers of artificial intelligence for the health care industry.
For questions about the Startup Roadshow, please contact Ohemah Addai at oaddai@ebglaw.com.
Download the Encore Lecture PDFs
Register for the Startup Roadshow: FDA Regulation of Artificial Intelligence Used in Healthcare
Much is changing with regard to how the U.S. Food and Drug Administration (FDA) approaches software generally, and artificial intelligence in particular. Some of that change is driven by the remarkable innovation going on right now at universities and in industry. But some of the change originates with the government. For example:
- In December 2016, Congress enacted the 21st Century Cures Act, which fundamentally changed the scope of FDA regulation of clinical decision support software.
- In December 2017, FDA published a draft guidance building on that legislation, providing the agency’s perspective on the clinical decision support software that FDA should regulate and what it should not. That guidance has profound implications for artificial intelligence used to guide healthcare decision-making.
- Throughout 2018, FDA engaged in a year-long process of completely revamping the agency’s approach to regulating software. FDA calls its new program the “Precertification Program.”
In assembling our speakers for the Startup Roadshow, we drew heavily from the medical software community already subject to FDA regulation. You will hear directly from experts as well as experienced medical software executives and Epstein Becker Green attorneys. For more information on the agenda, click here.
Dates/Locations
The Startup Roadshow will be held at the following locations:
- January 24, 2019: University of Michigan
- February 21, 2019: University of California, San Diego
- February 28, 2019: Georgia Tech
- March 26, 2019: Carnegie Mellon University
- April 12, 2019: Johns Hopkins University
- April 16, 2019: Rutgers University
- April 25, 2019: University of California Berkeley
- May 2, 2019: MATTER, in Chicago
For more information, please contact Wesley Hayden at whayden@ebglaw.com
Hosts
Sponsors
Additional Sponsors
Download the Presentation PDFs
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:
- How does the precertification program address low risk and ultra-low risk products?
- The need to include software used with drugs.
- Missing programmatic elements.
- What is FDA’s claimed legal authority for conducting the pilot program in 2019 and for implementing the program thereafter?
- 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
The CDS Coalition is distributing a survey designed to get input from the medical software industry on the FDA’s new vendor precertification program. FDA’s planned program will replace at least some product-specific premarket review for class II software medical devices, with precertification of software vendors to assess whether they meet quality guidelines the agency is still developing.
The survey assesses the extent to which software companies are willing to subject themselves to these additional quality screens, in exchange for the easier path to market. We are gathering this information to present the results at a public workshop FDA plans to hold in January 2018. We will continue to collect survey responses until January 12, 2018, giving us time then to analyze the results before the public workshop.
The survey targets vendors that develop, or plan to develop in the future, standalone software (meaning software that does not drive a hardware medical device) that FDA regulates in class II. The reason is simple: FDA’s objective is to lessen the premarket regulatory requirements for class II devices. Most class I medical devices do not undergo premarket review.
We are not asking participants to register because we want to afford them anonymity. While it’s probably impossible for survey participants to coordinate with all of their colleagues, we are interested in receiving only one response per company.
If your company is interested in participating, please click here to take the survey by January 12, 2018.
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.
Download in PDF format.
