Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in MobiHealthNews in “FDA Approves Dexcom’s CGM Accessory App Days After Relevant Draft Guidance,” by Jonah Comstock.
Following is an excerpt:
Bradley Merrill Thompson, a partner at Epstein Becker Green, says that the down classification of Dexcom’s smartphone apps is a significant move, as it follows closely on the FDA’s proposal in its new draft guidance that it would do just that. Even though the CGM remains a Class III device, apps that serve as an accessory to a CGM will no longer need to go through a class III process, thanks to Dexcom.
“This is indeed confirmation that FDA was serious in its accessories guidance in saying that it would be willing to down classify low risk accessories in response to a de novo request,” he wrote in an email to MobiHealthNews. “While there may only be a few companies that are interested in this particular technology, the FDA’s action displays a much broader willingness to treat accessories reasonably.”
So far, Dexcom is without competition in the smartphone-connected CGM business, but Medtronic announced something similar, its Guardian Mobile platform, back in September. There’s been no word on it since, but Dexcom’s FDA approval here may have helped pave the way for a smoother regulatory process for Medtronic. Thompson suggests this might point to a problem with the FDA’s new strategy.
“Dexcom had to undertake undoubtedly considerable expense to put together the de novo submission, and my hat is off to Dexcom for basically blazing the way for its direct competitors to follow,” Thompson wrote. “Unfortunately, not many companies are so willing to subsidize their competitors.”
