Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted RAPS Regulatory Focus, in “Industry Group Petitions FDA to Withdraw CDS Guidance,” by Ferdous Al-Faruque.

Following is an excerpt:

The Clinical Decision Support (CDS) Coalition has asked the US Food and Drug Administration (FDA) to withdraw its recent final guidance on CDS software, claiming that it oversteps the agency’s statutory authority and violates federal law. The group also said the policy would harm patients by dissuading innovation in the CDS software sector.
In September 2022, the FDA published a final guidance on CDS software, several years after releasing the draft document for consultation. In it, the agency raised concerns that physicians and other health care providers may become too reliant on such CDS products, even if such software is not meant to be the primary source of decision-making.
In particular, the agency said it plans to regulate products where there is a concern for "automation bias” that may lead to medical errors of commission, where providers follow incorrect advice, or omission, where they fail to act because they’re not prompted to do so.
While the CDS Coalition and other stakeholders have voiced their objection to FDA’s decision to regulate products that may lead to automation bias, on 6 February, the group filed a petition requesting the agency withdraw the document.

In the petition, the CDS Coalition argues that the guidance not only attempts to regulate clinical practice, which is outside FDA’s authority, but also violates the 21st Century Cures Act, which sets limits on FDA’s authority to regulate certain CDS software functionality.
Bradley Merrill Thompson, attorney at Epstein Becker Green and the CDS Coalition’s general counsel, told Focus that the guidance puts companies in jeopardy because they must decide whether they should follow the guidance or what's stated in the 21st Century Cures Act. He said the petition gives companies legal cover and allows them to say they are acting in good faith by following their interpretation of the law.
“FDA is harming, not helping, public health by dissuading innovators from evolving CDS software for the betterment of the public and imposing arbitrary rules on technology development that do not serve their intended purpose,” the CDS Coalition stated in the petition.

The coalition was formed in 2012 after FDA held a 2011 public workshop to start the process of developing the CDS guidance. The group has given input to FDA on how it should regulate CDS software within the confines of the agency’s statutory authority. The group argues that FDA should exclude CDS software from regulation as a medical device if it is “suitably transparent” in allowing physicians to see how it developed a clinical recommendation.
“The rationale for that policy approach was the need to articulate the dividing line between FDA jurisdiction and the practice of medicine overseen by state boards of medicine,” said the CDS Coalition. “If the software was transparent such that the users could reach their own conclusions without reliance on the software, any error the users make is properly within the jurisdiction of the state regulators overseeing the practice of medicine.”
The CDS Coalition notes that FDA declined their recommendations on the guidance, which led it to take their case to congressional lawmakers to limit the agency’s regulatory oversight of CDS software. Their efforts ultimately led to language in the 21st Century Cures Act that excluded regulating CDS software that was not intended to acquire, process or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system or for the purpose of displaying, analyzing or printing medical information about a patient or other medical information.

They also argue the text of the law excluded FDA from regulating software meant to support or provide recommendations to physicians about preventing, diagnosing or treating a disease. Furthermore, they said FDA is meant to exclude products that are transparent and allow physicians to see how the software came to its decision.
The CDS Coalition said in their petition that FDA is trying to do an “end run around” the 21st Century Cures Act by giving itself additional authority in the final guidance. Thompson said the petition sets the stage for the agency to sit down with stakeholders and directly hear from them about their grievances.
"Our plan is to have a dialogue with the FDA focused and organized around the citizen petition but we plan to engage in a dialogue if they'll talk to us and express our concerns,” Thompson said. “We don't just disagree philosophically with the agency, we think they're legally wrong.”
Thompson declined to comment on next moves if FDA were to reject their demands.

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