Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in “Top Democrats Question FDA Pre-Cert Program Safety, Statutory Authority,” by David Lim.
Following is an excerpt:
The FDA appears to be confident within its authority. Bakul Patel, the agency’s associate center director for digital health, said at The MedTech Conference late last month it plans to implement the pilot program through its current powers.
The concern that FDA may be overstepping its authority echoes comments submitted by the Clinical Decision Support Coalition, an industry group that has been active in responding to the FDA’s development of the Pre-Cert program.
“The agency has waffled between wanting to simply wait to evaluate legal authority, and developing a program that could be supported by existing statutory authority,” Brad Thompson, general counsel for the CDS Coalition, tells MedTech Dive.
“Senators raise legitimate questions about whether what FDA is planning could be done within the existing statutory authority,” he wrote in an email.