Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Medtech Insight, in “FDA Passes the Buck on LDTs, but Floats Ideas,” by Ferdous Al-Faruque. (Read the full version – subscription required.)
Following is an excerpt:
“If FDA is right that this very light touch is all that’s necessary, we should apply the same principles to existing IVD manufacturers,” attorney Brad Thompson says.
Overall, Thompson says the paper lays out a thoughtful and practical analysis that is well supported with evidence.
“Indeed, the agency shows that it is not being imperialistic, trying to expand its regulatory zone,” Thompson told Medtech Insight. “The agency seems quite willing to work with many other stakeholders including CMS, but also third parties such as the New York State Department of Health’s Clinical Laboratory Evaluation Program. FDA cogently lays out a role for each of the stakeholders that shows that each one can be called upon to use their core expertise in a complementary way.”