Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Bloomberg Law Health Law & Business, in “FitBit, Verily Make Inroads at FDA as It Weighs Software Rules,” by Ayanna Alexander.
Following is an excerpt:
Health tech giants … with an eye towards the future of smart medical devices are making inroads with federal officials exploring ways to regulate computer coding.
While volunteers in the Food and Drug Administration’s pre-certification pilot program won’t necessarily see their products hit the market faster, the experience could give them the inside track as the agency develops new approval methods for software-based medical devices.
Initial pilot participants said advancing digital health innovation is motivation enough, especially since the market for “smart” medical devices is large and expected to grow. …
The pre-certification program could also change as the FDA evaluates the results, which means participating companies may not see real benefits from it, Bradley Merrill Thompson, a member of Epstein Becker Green, said.
“In the future if the program is ultimately adopted, the final version is quite likely to be different from the piloted version,” Thompson said. “So, determinations that FDA makes during the pilot program may well not even carry over to the permanent program.”