Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in POLITICO, in “Lower Medicare Part B Premiums May Be Short-Lived,” by Lauren Gardner, David Lim, and Katherine Ellen Foley.
Following is an excerpt:
On Tuesday, the FDA published final guidance outlining when clinical decision support software is exempted from being regulated as a medical device.
The long-awaited policy document drew mixed reactions from industry and experts. Bradley Merrill Thompson, a medical device attorney at Epstein Becker & Green, argued the policy document violates the 21st Century Cures Act statute.