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Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MobiHealthNews, in “FDA Floats New Draft Guidance, Created by International Group, on Software as a Medical Device,” by Jonah Comstock.
Following is an excerpt:
Bradley Merrill Thompson, a partner at Epstein Becker Green who specializes in the FDA and digital health, said there are a few interesting aspects to this guidance, starting with the fact that it was created by an international body and the FDA is adopting it as their own.
“The International Medical Device Regulators Forum frankly has no authority under US law,” he told MobiHealthNews in an email. “So I think there’s a problem with saying that this document – when finalized by an international body – will become US law. Honestly I think if FDA wants to adopt the final IMDRF guidance as US policy, the agency will need to publish in the future the final IMDRF guidance and solicit comment on it. I understand why the FDA wanted to solicit comments now, because this is an opportunity to influence the final IMDRF document. So perhaps this will require two different comment periods.”