Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was cited in MobiHealthNews, in “A Closer Look at the FDA’s Moves, Clearances in the Second Half of 2019,” by Dave Muoio and Laura Lovett.
Following is an excerpt:
The back half of 2019 saw an FDA in the midst of a transition — both in terms of personnel and in digital regulation strategy. …
And while many eyes will be on high-profile health issues such as underage vaping and the opioid epidemic, those with an interest in digital health will be keen to see the agency’s ongoing efforts to revamp the regulation of these novel products.
Take, for instance, the FDA’s Pre-Cert Program. Early in the second half of 2019 the agency released a Mid-Year Update of the program’s Working Model one-year pilot. At the time, the agency reported that its retrospective testing of the original nine pilot participants was complete and that prospective testing was in progress. Not too long afterward, pilot participant Pear Therapeutics announced that Somryst, its experimental digital treatment for chronic insomnia and depression, would be the first software as a medical device product to be submitted for marketing approval through the novel pathway.
The FDA is still on the hook for an end-of-year update on the pilot program’s progress, but the past couple of months have had certain onlookers questioning Pre-Cert’s unique approach to regulation. At the end of October, Senators Elizabeth Warren, Patty Murray and Tina Smith penned an open letter to the agency expressing concern over the program’s potential impact on public safety. Some of these points were echoed in an op-ed by regulatory law expert and industry spokesperson Bradley Merrill Thompson, who also worried that precertification would come at the detriment of a lively startup environment.