Bradley Merrill Thompson Quoted in “FDA Finalizes Guidance on Software Modifications”

POLITICO Morning eHealth

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 POLITICO Morning eHealth, in “FDA Finalizes Guidance on Software Modifications,” by David Pittman.

Following is an excerpt:

If you made a big list of all the issues digital health companies had with FDA regulations, modifying software is near the top of the list. Developers would like to modify software a lot (as they do in the consumer sector); FDA’s regulations, designed for hardware, see changes as consequential and requiring oversight.

FDA’s finalized guidance, issued Tuesday, concerning when the agency will require new clearance for modified software, isn’t likely to soothe developers much, Epstein Becker & Green lawyer Bradley Thompson told Morning eHealth. “If it’s an improvement, it’s only a marginal one,” he said, adding that he hadn’t finished comparing the draft and final guidance. Instead, Thompson said, he is looking forward to seeing progress on the agency’s pre-certification pilot, a program explicitly designed to handle the types of intensive modifications developers want to make. Check out an FDA blog on the topic.

FDA digital health guru Bakul Patel reaffirmed during a MedCityNews conference Tuesday the agency hopes to release clinical decision support guidance in early 2018.