Bradley Merrill Thompson Quoted in “Scope Blamed for Superbug Infections Not FDA Cleared”Medical Device and Diagnostic Industry March 5, 2015
Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Medical Device and Diagnostic Industry, in “Scope Blamed for Superbug Infections Not FDA Cleared,” by Marie Thibault.
Following is an excerpt:
“It’s actually probably more common than you would think that industry and FDA disagree on whether a new 510(k) is needed or not,” says Brad Thompson, a member of Epstein Becker & Green in the healthcare and life sciences practice and a member of MD+DI’s editorial advisory board. …
“The problem is, over the years, there’s been a fairly significant shift in the way FDA wants to draw that line,” Thompson says, referring to the line determining when a modification necessitates a 510(k) submission.