As part of a series of digital heath-focused policy releases, the Food and Drug Administration (FDA) published a draft guidance on Dec. 7 to clarify the scope of the agency’s regulatory authority over clinical and patient decision support software.
The draft guidance is a major component of FDA’s implementation of Section 3060 of the 21st Century Cures Act, which specified the types of medical and clinical decision support (CDS) software functionalities that can be defined as a “medical device” subject to FDA oversight.
In accordance with the statutory restrictions on FDA’s authority from the Cures Act, appropriate use criteria (AUC) CDS delivery software would not be subject to the agency’s oversight. Modern AUC CDS software would need to meet all four of the following criteria for exclusion from the medical device definition:
- 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; and,
- 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); and,
- Intended for the purpose of supporting or providing recommendations to a health care professional about prevention, diagnosis, or treatment of a disease or condition; and,
- Intended for the purpose of enabling such health care professional to independently review the basis for such recommendations that such software presents so that it is not the intent that such health care professional rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient.
The draft guidance indicated that other radiology and radiation oncology-related CDS functionalities that do not meet these criteria will continue to be regulated as before. Examples include functionalities that manipulate/analyze medical images, plan radiation therapy treatments, etc.
The FDA also released two other digital heath guidances on Dec. 7 regarding Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act and Software as a Medical Device: Clinical Evaluation.
ACR members may contact Michael Peters, ACR director of regulatory and legislative affairs, with questions or comments about FDA’s digital health policies.