Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in Law360, in “FTC Stays Tough On Health Software, Even As FDA Eases Up,” by Jeff Overley.
Following is an excerpt:
“It is extremely important that mobile app manufacturers, as well as all other stand-alone software developers, need to remember that it is not just FDA that regulates medical-type claims based on software,” Epstein Becker Green member Bradley Merrill Thompson said. …
“Because there’s no preclearance requirement, it generally all comes down to data,” Thompson said. “Here, apparently FTC felt the claims far exceeded what the data showed.
