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 FierceHealthcare, in “Apple and Fitbit Among the 9 Companies Selected for FDA’s Coveted Digital Health Pilot,” by Evan Sweeney.
Following is an excerpt:
Bradley Merrill Thompson, a medical device attorney with Epstein Becker Green, said in an email to FierceHealthcarethat the investment the nine companies will make in the pilot program signals a long-term commitment to class II medical devices, a classification that allows them to make medical claims.
“There’s no point in doing this for only one product,” he said. “The only way it makes sense to invest the time necessary in the pilot will be if you intend to be a long-term participant in the class II marketplace.”
For those following Apple’s encroachment into healthcare, it’s a signal that “recent product announcements, as well as probably ones that have not yet been publicly shared, will be aimed at the class II level of claims,” he added.
Thompson also acknowledged the huge opportunity for these companies to take part in an entirely new paradigm for medical device regulation.
“They will learn a great deal, develop relationships with FDA and probably influence the direction the program takes.”