Friday, November 25 2022


On September 27, 2022, the Food and Drug Administration (FDA) released its long-awaited final guidance for industry and FDA staff, Clinical decision support software. This guidance follows the draft guidance on clinical decision support software published on September 27, 2019. The final guidance is particularly important as developers seek clarification on the regulatory status of software features that use algorithms to take into account support or provide clinical decisions for use by health care providers. (HCP). Although the draft guidelines gave its opinion on clinical decision support software (CDS) intended for use by patients are caregivers, the final guidelines noted that the FDA’s existing digital health policies continue to apply to those software functions, such as software functions that support or provide recommendations to patients or caregivers – not healthcare professionals – meet the definition of a device.

The FDA regulates software that meets the definition of a device in Section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which includes software intended to support HCP decision making regarding the diagnosis, treatment, prevention, cure, or mitigation of disease or other condition, otherwise known as ADC. In its guidance, the FDA clarifies the types of CDS software functions that are excluded from the definition of a medical device by meeting the four criteria set forth in Section 520(o)(1)(E) of the FD&C Act, which requires that the device is:

(1) not intended to acquire, process or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or a signal from a signal acquisition system (Criterion 1);

(2) intended to display, analyze, or print patient medical information or other medical information (eg, peer-reviewed clinical studies and clinical practice guidelines) (Criterion 2);

(3) intended to support or provide recommendations to an HPC regarding the prevention, diagnosis, or treatment of a disease or condition (Criterion 3); and

(4) intended to enable such healthcare professionals to independently review the basis for such recommendations that this software presents so that it is not intended that such healthcare professionals primarily rely on the one of these recommendations for making a clinical diagnosis or treatment decision for an individual patient (Criterion 4).

Criterion 1

The FDA considers software functions that assess or interpret the clinical implications or clinical relevance of a medical signal, pattern, or image to be software functions that do not meet Criterion 1 because they acquire, process, or analyze . These devices are subject to FDA regulation and oversight. Note, however, that activity monitors or other signal acquisition systems that measure physiological parameters that are not specifically intended or marketed for a purpose identified in the device definition are not medical devices.

Criterion 2

Software functions intended to display, analyze or print medical information about a patient or other medical information (for example, peer-reviewed clinical studies or clinical practice guidelines) meet criterion 2 and are not devices medical products subject to FDA regulation and oversight.

The FDA explains that Criterion 1 and Criterion 2 describe the types of data inputs used in devices (Criterion 1) and the types of data inputs used in non-device CDS (Criterion 2).

Criterion 3

The FDA interprets Criterion 3 to refer to software that provides condition, disease, and/or patient-specific recommendations to an HCP to improve, inform, and/or influence a healthcare decision (e.g. , drug interaction and drug allergy contraindication notifications to avoid adverse drug events) but is not intended to replace or guide the judgment of a healthcare professional and does not include in the taking of urgent decision or a specific result or directive for prevention, diagnosis or treatment. Criterion 3 software functions present recommendations based on an analysis of patient-specific information to an HCP, who can then incorporate that information into their decision-making about a patient’s care, along with other information and factors including the HCP is aware. In contrast, software that provides a specific preventive, diagnostic, or treatment output or directive or processes an urgent decision would be an FDA-regulated medical device subject to FDA oversight.

The FDA notes that two aspects of software functionality can affect the use of a software function to support or provide guidance to an HCP: (1) the level of software automation and (2) the critical nature of the decision decision of the HCP. Automation bias can occur if the software provides a healthcare professional with a single, specific, and selected output or solution, as opposed to a list of options or comprehensive information for the healthcare professional. .

Criterion 4

According to criterion 4, the software function must be intended to allow healthcare professionals to independently review the basis of the recommendations presented by the software so that they do not rely primarily on these recommendations, but rather on their own judgment, to make clinical decisions for individual patients. . The FDA explains that regardless of the complexity of the software and whether it is proprietary or not, the output or labeling of the software must provide adequate background information in plain language about the inputs, logic, or methods of the algorithm, datasets and validation. In addition, relevant sources must be identified and available and understandable by the HCP user.

The final guidance released by the FDA includes several examples of device and non-device CDSs, which should be carefully considered by developers when inking an FDA regulatory strategy.

Foley is here to help you deal with the short and long term impacts as a result of regulatory changes. We have the resources to help you navigate these important legal considerations related to business operations and industry-specific issues. Please contact the authors, your Foley relationship partner, or our healthcare practice group with any questions.

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