Bradley Merrill Thompson Quoted in “How Apple, Fitbit, Samsung and More Are Helping to Modernize the FDA”

CNET

Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in CNET, in “How Apple, Fitbit, Samsung and More Are Helping to Modernize the FDA,” by Danielle Kosecki.

Following is an excerpt:

What challenges does the Pre-Cert Program face?

The biggest challenge will be fleshing out all of the details missing from version 1.0, which the FDA released in January. “I actually think 1.0 is a bit of a misnomer,” regulatory lawyer Bradley Merrill Thompson wrote in MobiHealthNews. “It ought to be labeled something like version 0.7, because it’s really about 70% of a complete proposal. It lacks many of the details necessary to give an understanding of how it will work.”