Bradley Merrill Thompson Comments on the FDA’s Pre-Certification Program Working Model

POLITICO Morning eHealth

Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in POLITICO Morning eHealth, in “Comments,” by Darius Tahir.

Following is an excerpt:

Not everyone is totally positive on FDA’s pre-certification program proposal. The Clinical Decision Support Coalition — run by Bradley Merrill Thompson — has submitted a fairly harsh comment, arguing that FDA has not filled in some of the regulatory details behind its proposal to upend software regulation by moving more scrutiny to software firms, not the products they develop. While the proposal has generally elicited praise from software companies and others in industry, there have been persistent questions about how it would work in practice.

The Coalition’s questions are part of this genre, asking how registration, listing, and adverse event reporting would work in the new system; or, for that matter, drug-software combinations.

FDA has generally been receptive to outside comments, emphasizing that the proposal is intended to be iteratively developed over time, so we’ll see how the program evolves.