Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in BioWorld, in “FDA's Device Center Vigorously Stirred the Regulatory Pot in 2024,” by Mark McCarty. (Read the full version – subscription required.)
Following is an excerpt:
CDS quagmire greets new CDRH director
One of the regulatory hot potatoes Tarver must deal in 2025 are the twin citizen petitions to the CDRH final rule for clinical decision support (CDS) products. The earlier of these two petitions was filed in the first half of 2023, and a recent Q&A document resurrected the controversy just in time for the 2024 holiday season. The key question for Tarver is whether she will engage with the petitioners at all, given the agency’s seeming intransigence regarding the final guidance.
The Q&A document seems to serve primarily to reinforce the agency’s stance on the final guidance, arguing that the guidance “did not bring new software functions” under the agency’s regulatory purview. That perspective is not universally accepted as counsel for the CDS Coalition has argued repeatedly. Brad Thompson of Epstein, Becker & Green PC has asserted a number of times that the guidance deviates from the language of Section 3060 of the 21st Century Cures Act, a charge that seems to have acquired little traction at the agency’s Office of Chief Counsel.
