William A. Hyman is a professor emeritus in the department of biomedical engineering at Texas A&M University and adjunct professor of biomedical engineering at the Cooper Union. Reach him at [email protected].
The definition of a biomaterial has evolved over time, but given today's efforts to better characterize medical device biocompatibility, is a catch-all term for some materials misleading?
The agency is encouraging innovation in digital health. But is software really so fundamentally different from hardware that it can’t be regulated in the same way?
Draft guidance from FDA offers a more specific way to demonstrate substantial equivalence for certain devices. But will it really be less burdensome?
What type of score will your company earn under FDA's Pre-Cert Program for Software as a Medical Device (SaMD)?