Bradley Merrill Thompson Discusses FDA’s Final Guidance on Low Risk Devices, in Multiple PublicationsMultiple Publications July 29, 2016
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 multiple publications regarding the U.S. Food and Drug Administration's final guidance on low-risk devices intended to promote general wellness, including mobile health and fitness apps.
Following is an excerpt from Health Data Management:
Bradley Merrill Thompson, an attorney at the Washington, D.C.-based law firm of Epstein Becker Green who counsels medical device companies on regulatory issues, applauded the agency for its approach in clarifying which products would be considered “low risk” and, through the examples it provided, which ones would not.
“Adding examples is extremely useful because it gives us more data from which we can infer exactly what FDA means,” says Thompson. “Indeed, in several cases, it seems that FDA broadened the examples, but in others narrowed them. For example, FDA deleted the reference to ‘cardiac function,’ presumably because the agency thinks that’s too risky to include in the unregulated category. The agency also sought to be more precise when referring to anxiety, differentiating I guess garden variety anxiety from anxiety disorder. That's a useful clarification.”
POLITICO Morning eHealth, 07/29/2016
Fierce Healthcare, 07/29/2016