Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was featured in Fierce Healthcare, in “Brad Thompson: FDA Software Guidance Provides Much-Needed Clarity,” by Judy Mottl.
Following is an excerpt:
Brad Thompson (pictured right), a health attorney at Epstein, Becker and Green, tells FierceMobileHealthcare that the guidances are very useful and provide some long-overdue clarity.
"Many folks in the mHealth market have been struggling in a sea of ambiguity for many years, but the Mobile Medical App Guidance and this guidance on software modifications provide a much clearer picture," he says.
Thompson adds that he hopes the FDA is "open-minded" when reviewing comments. The devil is in the details, Thompson notes, and he expects that the agency will receive quite a few useful and insightful comments.
In this interview, Thompson also discusses the impact of the recommendations on mHealth tool and software developers.