EBG Commentary

Bradley Merrill Thompson Quoted in “21st Century Cures Act Clarifies FDA Regulation of Software”

Health Data Management

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 Health Data Management, in “21st Century Cures Act Clarifies FDA Regulation of Software,” by Greg Slabodkin.

Following is an excerpt:

Bradley Merrill Thompson, an attorney at the Washington-based law firm of Epstein Becker Green, says that the vendor community has been waiting years for this kind of clarity on the type of clinical decision support software the FDA should regulate.

Thompson, who counsels medical device companies on regulatory issues, contends that there has been a cloud over the industry because of the uncertain regulatory environment.

“FDA says that they regulate high-risk clinical decision support software, but not low-risk software. That’s great, but how is a company supposed to discern high from low risk?” he says. “Companies have to know the answer to that question because it is fundamental to both the cost and timelines associated with product development.”

An FDA spokesperson said the agency does not comment on proposed or pending legislation.

“Health software companies are working on exciting technologies that help doctors do a more thorough job in both the diagnosis and treatment decision making process,” adds Thompson. “We are delighted to see that Republicans and Democrats have come together over these concepts to provide industry with the needed clarity.”