The U.S. Food and Drug Administration (FDA or Agency) recently issued a revised final guidance document addressing Clinical Decision Support (CDS) Software (the 2026 CDS Guidance). The 2026 CDS ...

A key section of the recently passed 21st Century Cures Act explained to the US Food and Drug Administration (FDA) which categories of software should be exempt from medical device regulations. Most ...

FDA has long expressed an interest in digital health products. The extent to which FDA should assert jurisdiction over digital health products, however, has been the subject of considerable debate.

The Clinical Decision Support Coalition comprises healthcare industry stakeholders – software developers, patient advocacy groups, clinical societies, providers and healthcare payers – working to ...

This morning the FDA released two guidance documents relating to the regulation of various digital health software devices. The first is a draft guidance outlining categories of clinical decision ...

The Clinical Decision Support (CDS) Coalition has asked the US Food and Drug Administration (FDA) to withdraw its recent final guidance on CDS software, claiming that it oversteps the agency’s ...

An industry coalition has finalized guidelines on the design and development of medium-risk clinical decision support software that aren’t subject to Food and Drug Administration review. The aim of ...