Bradley Merrill Thompson Quoted in “FDA Green-Lights 14 Digital Health Products, Continues to Evolve Regulations”


Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MobiHealthNews, in “FDA Green-Lights 14 Digital Health Products, Continues to Evolve Regulations.”

Following is an excerpt:

Interest in digital health is now sprouting up all over DC, from the president’s announcement of a new AI task force to FDA Commissioner’s shout out to digital health in his budget request.

In fact, the FDA is turning to developers in the digital health space to help solve some of the country’s most difficult problems. In May, the agency announced an innovation challenge aimed at tackling the opioid epidemic, where developers could share their approaches to detecting, treating, and preventing addiction.

The agency is also making some new moves when it comes to regulation. Notably, in June the agency ruled that genetic risk tests are officially exempt from requiring 510(K) premarket approval, provided the company offering the test has gone through a one-time premarket review of its testing apparatus and at least one test. The guidance was originally proposed in November 2017. …

But the drafts are not without critics. Bradley Merrill Thompson, a partner at Epstein Becker Green ... said the draft is asking the industry to give the FDA more power and control. Thompson went on to say software that used to fall under enforcement discretion will now be part of the framework and premarket reviews will be more involved.

“This is a good old-fashioned trade,” Thompson said in an email to MobiHealthNews in April after the first draft guidance. “Industry wants faster approvals. FDA wants more control over industry. So FDA’s proposing an exchange: faster approvals for more FDA authority.”

The verdict is still out on the draft guidance and the agency is still taking comments on the draft until July 19.