Bradley Merrill Thompson Quoted in “FDA Aims to Ease Medical Device Approval Burdens”Bloomberg BNA Medical Devices Law & Industry Report December 15, 2017
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 Aims to Ease Medical Device Approval Burdens,” by Mike Stankiewicz. (Read the full version – subscription required.)
Following is an excerpt:
The FDA is taking steps to reduce the amount of burden on medical device makers during approval processes, according to draft guidance released Dec. 14. …
Bradley Merrill Thompson, a health-care attorney at Epstein Becker & Green PC in Washington, said the FDA has talked about supporting innovation in the past, but recently has taken it up to a whole new level.
“Christmas came early this year,” he told Bloomberg Law Dec. 14. “Not only is FDA radically expanding the scope of the least burdensome concept to basically include all things medical device, but the sheer range of ideas that FDA is putting forth for alternatives to the traditional clinical trial is, to a guy who’s been doing this over 30 years, simply mind blowing.” Thompson is a Bloomberg Law advisory board member.
Thompson, however, said words are one thing and action is another.
“There are very few commitments in this document that industry can take to the bank,” he said. “[But] the changes have to start somewhere, and this document would seem to portend significant changes.”