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 the Bloomberg BNA Medical Devices Law & Industry Report, in “FDA Proposal Would Lower Requirements for Some Moderate-Risk Devices,” by Bronwyn Mixter. (Read the full version – subscription required.)
Following is an excerpt:
Bradley Merrill Thompson, a Washington-based attorney with Epstein Becker & Green PC, told Bloomberg BNA in a March 20 email the FDA’s list is longer than he expected, which is good news because he was afraid the FDA would exempt just a few categories of medical devices. Thompson counsels medical device, drug and combination-product companies on a wide range of FDA issues. He’s also a Bloomberg BNA health-care advisory board member.
“The proposed list is pretty comprehensive, covering most areas of medical devices,” Thompson said. “The purpose of this exercise is both to save industry resources developing unnecessary premarket submissions, but also to conserve agency resources for those products that really need oversight.”
Thompson said the list “will help FDA focus its attention on those technologies that really need premarket review.”
