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 Bloomberg BNA Health Care Daily Report, in “Global Group Offers Guidance on Medical Software,” by James Swann. (Read the full version – subscription required.)
Following is an excerpt:
Thompson did identify a problem with the FDA's approach to the guidance, noting that it's proposing to adopt a document that it won't be finalizing. Instead, the IMDRF will finalize the guidance, and Thompson said the group has no authority under U.S. law.
“Honestly I think if FDA wants to adopt the final IMDRF guidance as U.S. policy, the agency will need to publish in the future the final IMDRF guidance and solicit comment on it,” Thompson said.
Thompson said he understood why the FDA was soliciting comments on the draft guidance, as it would give the public the chance to influence the final guidance. However, he said there probably will have to be another comment period after the IMDRF finalizes the guidance.