What Is Software as a Medical Device? A Practical Definition for Health Tech Leaders
Software as a Medical Device (SaMD) defined: software that performs a medical function without being part of a hardware device, regulated by the FDA.
Health technology runs on vocabulary, and few terms carry more weight in current strategy conversations than Software as a Medical Device (SaMD). Here is what it means, why it matters, and the context every reader of our policy & regulation coverage should have.
The definition
Software as a Medical Device (SaMD) is software that performs a medical function without being part of a hardware device, regulated by the FDA. In practical terms, clearance pathways for SaMD are the gateway for diagnostic AI and digital therapeutics.
Why it matters now
Consider the current numbers: cMS launched a dedicated Office of Health Technology Products to steer AI and interoperability policy (our coverage).
Meanwhile, the FDA-CMS TEMPO pilot ties regulatory evaluation to real-world outcomes and Medicare coverage, with Dexcom as its first participant (our coverage).
Where you'll see it in our coverage
The term appears throughout our Policy & Regulation reporting and the related topic feeds, where the companies, policies, and studies shaping it are tracked daily. When headlines reference Software as a Medical Device, this page is the grounding to read them with.
The bottom line
For leaders building 2027 plans, this belongs on the shortlist of capabilities to own rather than outsource.