Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in POLITICO Morning eHealth, in “FDA’s Call for Volunteers,” by Mohana Ravindranath.
Following is an excerpt:
The FDA wants more participants to help test its software regulation pilot, Darius reports. So far it’s had nine participants … in the pre-certification program. Multiple pre-pilot participants have said their peers were not particularly active during policy discussions, Darius reports — though FDA has denied that assertion. …
The move to open up the program raised skepticism from observers, including Epstein Becker Green lawyer Bradley Merrill Thompson. “That was not the plan as recently as January,” he told Morning eHealth. “They thought they had enough to do with just the nine pilot participants. It makes me wonder if some of the nine have needed to drop out for some reason.”