The purpose of FDA’s final guidance is to describe its regulatory approach to CDS software functions, clarify the types of CDS software functions excluded from the definition of device, and give examples of CDS software that FDA considers nondevice CDS software.

On September 28, 2022, the U.S. Food and Drug Administration issued a final guidance regarding how FDA classifies different kinds of clinical decision support (CDS) software as nondevice CDS software exempt from regulation as a device under Section 201(h) of the Federal Food, Drug & Cosmetic Act (FDCA). CDS software provides healthcare professionals (HCPs) and patients with individual-specific information to enhance health and healthcare by, for example, intelligently filtering or presenting the information at appropriate times. FDA’s newly issued guidance finalizes two draft guidance documents issued by FDA on December 8, 2017, and September 27, 2019.

FDA regulates and oversees CDS software functions that meet the definition of devices as set forth in Section 201(h) of the FDCA. However, if a type of CDS software function meets the criteria to be considered a nondevice CDS software, it is not regulated by FDA as a device. The purpose of FDA’s final guidance is to describe its regulatory approach to CDS software functions, clarify the types of CDS software functions excluded from the definition of device, and give examples of CDS software that FDA considers nondevice CDS software.

CDS software functions are only excluded from the definition of device if all four criteria set forth in Section 520(o)(1)(E) of the FDCA are met:

1. 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 (Criterion 1);
2. Intended for the purpose of displaying, analyzing or printing medical information about a patient or other medical information (such as peer-reviewed clinical studies and clinical practice guidelines) (Criterion 2);
3. Intended for the purpose of supporting or providing recommendations to a healthcare professional about prevention, diagnosis or treatment of a disease or condition (Criterion 3); and
4. Intended for the purpose of enabling such healthcare professional to independently review the basis for such recommendations that such software presents so that it is not the intent that such healthcare professional rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient (Criterion 4).

If a CDS software function meets all four criteria, it is classified as a nondevice CDS software function. FDA’s final guidance explains its interpretation of each applicable criterion and gives examples of software functions that do or do not qualify as nondevice CDS software functions.

First, Criterion 1 describes a software function that acquires, processes or analyzes certain inputs, including medical images, signals from in vitro diagnostic devices or patterns from signal acquisition systems. If CDS software processes or analyzes these inputs, the CDS software remains a device subject to FDA oversight and will not be considered a nondevice CDS function. In other words, Criterion 1 is not met if the CDS software function assesses or interprets the clinical implications or clinical relevance of, for example, a medical image like an X-ray or ultrasound (or other signals or patterns typically used by devices).

In contrast, Criterion 2 sets forth the type of data – i.e., medical information – that nondevice CDS software functions use as inputs. FDA interprets Criterion 2 to include CDS software functions capable of displaying, analyzing or printing medical information, including, for example, symptoms, discharge summaries, peer-reviewed clinical studies or approved drug labeling. If a CDS software function displays this type of medical information, then it is considered a nondevice CDS software function as long as it meets the remaining two criteria.

FDA interprets Criterion 3 as software that provides condition-, disease- or patient-specific recommendations to HCPs to enhance, inform or influence a healthcare decision. Importantly, however, a nondevice CDS software function is not intended to replace or direct the HCP’s judgment. FDA examines whether a recommendation provided by software function is intended to inform versus replace HCPs’ recommendations by examining (1) the level of software automation and (2) the time-critical nature of the HCP’s decision-making. For example, if a software function provides a specific diagnostic directive in a time-critical situation, FDA is likely to find the CDS software function fails Criterion 3 because it does not support or provide a recommendation to a HCP but rather replaces the HCP’s recommendation with the software’s directive.

Finally, for Criterion 4, in order for software to be considered a nondevice CDS software function by FDA, the software function must be intended to enable HCPs to independently review the basis for the recommendations presented by the software. A nondevice CDS software function does not enable HCPs to rely primarily on the software’s recommendations, but rather on the HCPs’ own judgment, in order to make clinical decisions for patients. FDA’s final guidance details a number of recommendations in order to satisfy Criterion 4, including, for example, that the software or labeling explains the intended use and purpose of the product.

In sum, nondevice CDS software functions display, analyze or print medical information (Criterion 2) in order to provide recommendations about a patient’s care to an HCP user (Criterion 3). Nondevice CDS software functions provide sufficient information about the basis for the recommendations to HCP, so that the HCP does not rely primarily on any of the recommendations to make a clinical decision about an individual patient (Criterion 4). Nondevice CDS functions do not supplant the judgment of HCPs (as a software function regulated as a device may do).

This final guidance provides manufacturers and developers further clarity in navigating regulatory requirements for their devices. It also provides further considerations during the development process to employ certain practices that may help mitigate products liability exposure in the future.

For More Information

If you have any questions about this Alert, the final guidance or its potential implication, please contact Frederick R. Ball, Sean K. Burke, Coleen W. Hill, any of the attorneys in our Life Sciences and Medical Technologies Industry Group, any of the attorneys in our Products Liability and Toxic Torts Group or the attorney in the firm with whom you are regularly in contact.

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