Bradley Merrill Thompson Mentioned in “Senate Tweaks Bill to Let FDA Step in If Health Software Poses Serious Risk”Inside Health Policy March 9, 2016
Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was mentioned in Inside Health Policy, in “Senate Tweaks Bill to Let FDA Step in If Health Software Poses Serious Risk.” (Read the full version – subscription required.)
Following is an excerpt:
Brad Thompson, regulatory counsel for the CDS Coalition, said the new serious adverse health consequences provision allows FDA to refine where the line gets drawn between regulated and unregulated products, saying it's really hard to accomplish this in a piece of legislation that's fairly short. He said the legislation is a huge step forward, but added that FDA would still need to provide guidance to industry if the bill becomes law because there are some gray areas.