The FDA, Clinical Decision Support Tools, and the Medical Device Industry

As patients, caregivers, and healthcare professionals rely more on digital healthcare tools and the development of those tools continues to accelerate, the industry has awaited direction from the U.S. Food and Drug Administration (FDA) on how it plans to apply its medical device authorities to clinical decision support (CDS) software. At the end of 2016, the 21st Century Cures Act (Cures Act) became law and modified the definition of a “medical device” to exclude certain software functions from regulation under the FDA’s device authorities when certain criteria are met.

Among those functions are practice and inventory management, determination of health benefit eligibility, and encouragement of a healthy lifestyle that does not involve diagnosis, cure, mitigation, prevention, or treatment of a disease or condition. Just before the new year, the FDA issued a draft guidance document explaining its implementation of the Cures Act definition of a device as it pertains to CDS tools and which tools it will regulate.

Understand the Cures Act Criteria

As outlined in the FDA’s draft guidance, criteria in the Cures Act can pull an excluded software function back under active regulation. These criteria include software intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or signal acquisition system for the purpose of:

  • Displaying, analyzing, or printing medical information about a patient or other medical information.
  • Supporting or providing recommendations to a healthcare professional about prevention, diagnosis, or treatment of a disease or condition.
  • Enabling [a] healthcare professional to independently review the basis for [the] recommendations that such software presents.

In its draft guidance, the FDA places particular importance on the final criterion of independent review of a CDS tool’s recommendations, citing independent verification by reference to literature or clinical practice guidelines as examples of providing a healthcare professional with the ability to cross-check and independently review recommendations. As a result, industry members looking to develop a CDS tool that relies on a proprietary algorithm would be cautioned from relying on the exclusion created under the Cures Act.

In particular, the FDA recommends in its draft guidance that the basis or rationale for a CDS tool’s recommendations be based on publicly available sources. Here, “data on file” that form the basis of a CDS tool’s recommendations would not be adequate under the FDA’s draft guidance for an industry member to qualify for exclusion from the FDA’s device authorities, even if all other criteria are met.

Interestingly, the “public” availability of the source or rationale is not enumerated as a criterion in the Cures Act itself. While the FDA’s draft guidance is helpful to industry in sharing its current views on implementation of the Cures Act exclusion for certain software functions, innovation in CDS tools along proprietary lines appears as though it will limit the medical device industry’s ability to qualify under the exclusion.

  • Julie Tibbets

    Julie K. Tibbets is a Partner at Goodwin Law. Julie is focused on all aspects of FDA-regulated product development, advertising, promotion, and corporate communications. Julie appears on the Washington, D.C. Super Lawyers list of “Rising Stars” and The Best Lawyers in America for FDA law.


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