The FDA’s guidance for clinical decision support (CDS) programs has proven unusually controversial, leading to the filing of two petitions that the agency withdraw the guidance. However, the FDA recently reaffirmed its position on the guidance, a position that some have argued is in conflict with the 21st Century Cures Act.
The FDA posted a Dec. 20, 2024, FAQ for the final guidance which lists the four criteria for determining whether a CDS system is outside the scope of regulations. One of these criteria is that the software provides information or options rather than a
specific output or a single recommendation for patient management. Another criterion is that the software must provide the basis for any recommendations so that the health care professional does not rely primarily on the recommendation to arrive at a clinical decision.
The agency published the final guidance in September 2022, which was followed by a citizen petition filed by the Clinical Decision Support Coalition in February 2023. This petition requests that the final guidance be amended to allow CDS software to make a single recommendation for patient treatment/management.
The Coalition, which was formed in 2012, stated that the 21st Century Cures Act does not stipulate that a non-regulated CDS product offer more than one recommendation, and that the final guidance is consequently misaligned with the Cures Act. The petition highlights several other aspects of the guidance said to be in contravention of the Cures Act, but the agency has yet to respond.
A law professor at the University of Florida filed a petition in July 2023 that requested that the FDA withdraw the guidance on the grounds that it violates the First Amendment. The petitioner, Barbara Evans, said the guidance raises constitutional concerns that justify an internal investigation by the FDA commissioner. Evans said the guidance restricts the information accessed by a physician for patient care, which in turn restricts the physician’s ability to convey appropriate information to the patient. The FDA has not responded to this petition, either.
The FDA’s FAQ states that software intended for simple medical calculations that are routinely used in clinical practice are outside the scope of the agency’s non-device policy for CDS. However, the FDA intends to exercise enforcement discretion for these functions, partly because such calculations can be performed manually.
However, a CDS intended to support time-critical clinical decision making does not meet the definition of a non-device software function and consequently is regulated as software as a medical device. The agency said this is because a physician may not have time to evaluate the information that led to a CDS recommendation for patient care, although there are exceptions. Among these are CDS software that retrieve patient information such as lab results and patient medical history.
While the CDS guidance is still the subject of controversy, the FDA has already acted on the guidance in its enforcement activities. As an example, one of the areas of significant ambiguity in the guidance, and potentially an enforcement hazard, is the second criterion for determining whether a CDS is a regulated product. The second criterion states that medical information is the type of information that may be discussed between two clinicians or between a clinician and a patient during clinical decision-making processes. The lack of clarity as to how the agency will apply this and other criteria may lead to enforcement actions for products already on the market.
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