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 Health Data Management, in “FDA to Create Centralized Digital Health Unit,” by Greg Slabodkin.
Following is an excerpt:
Bradley Merrill Thompson, an attorney at Washington-based law firm of Epstein Becker Green who counsels medical device companies on regulatory issues, says that industry has long supported medical device users fees and the concept of an FDA digital health unit.
“On the whole, industry has been hoping that FDA would create this office for years, and indeed it was a specific recommendation of the FDASIA working group a few years ago, so it is great that it will finally come to be,” Thompson notes.
At the same time, he warns that the problem for the agency will be recruiting staff for the digital health unit. “Right now salaries for people in those domains are sky-high, and that means many folks are very nervous about how FDA will succeed in recruiting the talent it needs,” adds Thompson. “For example, machine learning is a key knowledge base that FDA should have going forward, but machine learning people are in extremely scarce supply.”