FDA releases draft guidance on clinical and patient decision support software and their regulatory status

Clinical decision support software (CDS) can compare patient-specific signs with available clinical guidelines to recommend treatments. Such products are intended to provide decision support for the diagnosis, treatment prevention, cure, or mitigation of diseases or other conditions.

The US Food and Drug Administration (FDA) has recognised that the term “clinical decision support” is used broadly and in different ways, depending on the context. The FDA has therefore released draft guidance on the different types of CDS products and their functionalities, and has aimed to clarify which products do, or do not, fall within the definition of a medical device.

Typically, CDS that allows for the provider to independently review the basis for the recommendations are excluded from the FDA’s regulation. Lower-risk decision support software intended to be used by patients or caregivers, such as software that reminds a patient of how or when to take a prescribed medicine, are also not enforced by regulatory requirements. Mobile applications or certain step trackers that are intended only for maintaining or encouraging a healthy lifestyle generally fall outside the scope of FDA’s regulation.

Software that uses analytical functionalities to make treatment recommendations, for example software to process or analyse medical images or signals from in vitro diagnostics, will remain a medical device under the 21st Century Cures Act and the FDA will continue to enforce the oversight of this software.

Final guidance known as “Software as a Medical Device: Clinical Evaluation” has also been released by the FDA. The final guidance, which was drafted in October 2016, expands on the draft and sets out common principles for regulators to use in evaluating the safety, effectiveness and performance of software as a medical device (SaMD).

To view the FDA draft guidance on clinical and patient decision support software, please click here.