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 MobiHealthNews, in “Scoop: Emails Show FDA Asked Apple to Advise on Software as a Medical Device,” by Heather Mack.
Following is an excerpt:
That email came shortly after the IMDRF published a consensus document entitled Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations. Bradley Merrill Thompson, a partner at Epstein Becker Green who specializes in the FDA and digital health, wrote a post for MobiHealthNews in February 2015 in which he wrote, “The document is instructive for our purposes because FDA was heavily involved in drafting it. To be sure, it is also the product of compromise among international regulators. But I also can’t see FDA ignoring the document when the agency’s fingerprints are all over it.”