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 Medical Devices Law & Industry Report, in “FDA Says It Will Clarify Digital Health Regulations,” by Mike Stankiewicz. (Read the full version – subscription required.)
Following is an excerpt:
“During the winter, before Dr. Gottlieb took over, FDA seemed still unsure what to do,” Bradley Merrill Thompson, a health-care attorney at Epstein Becker & Green PC in Washington, told Bloomberg BNA Jun 16. “It’s amazing what an election will do. Now FDA seems to be committed to publishing guidance in the coming months.”
The FDA plans to go beyond the legislation and provide guidance on other low-risk items not covered under the 21st Century Cures Act, that will not be subjected to certain premarket regulatory requirements so the agency can give more attention to higher-risk priorities. “Legislation always covers at best a few of the larger categories, and there is truly much more work to be done,” Thompson said.
