Bradley Merrill Thompson Discusses How the FDA’s Final Guidance on Low-Risk Devices Will Affect Wearables, in Multiple PublicationsMultiple Publications August 2, 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 how the U.S. Food and Drug Administration’s final guidance on low-risk devices will affect wearable and mobile health technologies.
Following is an excerpt from MedTech Insights (read the full version – subscription required):
Overall, Thompson says the draft guidance, and now the final guidance, gives companies some assurance about whether or not their product will be regulated and, if they are regulated, what requirements the agency would like to see met.
"Over the intervening year and a half, I have talked to a lot of developers of wearable technologies and associated mobile apps and have used the draft guidance as a roadmap for how to assess FDA jurisdiction," he said. "I have found it to be extremely practical, and to reach the right conclusion from a societal perspective. I think it strikes the right balance between regulation and innovation. So I continue to applaud FDA."
Healthcare Dive, 08/01/2016