Last June in a draft guidance document, the FDA proposed to further de-regulate a specific type of health software, which included a number of mobile medical apps and telehealth platforms, from ...

A decision by the Food and Drug Administration to recognize a set of voluntary, industry-developed interoperability standards should make it easier for technology developers to gain 510(k) clearance ...

Bakul Patel, the US Food and Drug Administration’s (FDA) former digital health chief, said he’s always known the agency needed additional congressional authorities to fully implement a new digital ...

With ongoing work on guidance related to software as a medical device, and a new dedicated unit to digital health coming to the US Food and Drug Administration’s Center for Devices and Radiological ...