Bradley Merrill Thompson Quoted in “Device Expert Worries FDA Might Not Get Takers for Pre-Cert Test Plan”

Inside Health Policy

Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Inside Health Policy, “Device Expert Worries FDA Might Not Get Takers for Pre-Cert Test Plan,” by David Roza. (Read the full version – subscription required.)

Following is an excerpt:

A medical device regulatory expert raised concerns that companies may see no benefit from participating in FDA’s newly announced plan to test its software precertification program, and, given the added burdens of doing so, there might not be enough volunteers to properly test the program.

But the expert suggested that device makers might eventually see shortened review times if the pre-cert test is successful. …

“[G]iven what appear to be significant efforts to participate, we remain concerned that there may not be enough volunteered submissions to adequately validate the program,” wrote Adrienne Lenz, senior medical device regulation expert for Hyman Phelps & McNamara, in a post for FDA Law Blog on Wednesday (May 29). …

Lenz’ concerns about the burdens of participating echoed those of Brad Thompson, a member of the firm Epstein Becker Green. Thompson recently told Inside Health Policy that companies had even less reason to participate, given the uncertainty over whether FDA has the authority to proceed with pre-cert.