Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in POLITICO Morning eHealth, in “Google’s App a Medical Device?”
Following is an excerpt:
At the behest of UK medical device regulator MHRA, Google registered Streams as a low-level device, and could only market it after the app had been fully certified, CE-marked and registered, a company spokesman said.
Our curiosity was piqued — does this mean anything with respect to U.S. regulatory policy? Probably not, says Bradley Merrill Thompson, a digital health expert with Epstein, Becker and Green. It all depends on FDA’s guidance on clinical decision support, which the agency hasn’t released yet.
