As Prescribed

The FDA released updates to two guidance documents on January 6: General Wellness: Policy for Low Risk Devices (General Wellness) and Clinical Decision Support Software (CDS). FDA did not issue a traditional press release; instead, FDA Commissioner Makary took to social media to announce the updates in a video, in which he touted them as “promot[ing] more innovation with AI and medical devices” and that FDA has “a clear lane for medical grade products,” but needs “to adapt with the times and be proactive with guidance.” Consistent with the Commissioner’s messaging, the updates to the General Wellness guidance expand the types of products that qualify for enforcement discretion (i.e., do not need to comply with FDA’s device requirements). The updates to the CDS guidance, however, do not appear to significantly modify FDA’s interpretation of the CDS exemption. Nonetheless, these updated guidance documents signal FDA leadership’s willingness to ease regulatory burdens for digital health and wearables.

On December 8, 2025, FDA announced a pilot for certain digital health devices in connection with the Center for Medicare and Medical Innovation’s (CMMI’s) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) payment model.