In the Headlines
December 6, 2024
Attorneys Expect OTC Drug User Fee Deal to Shed Light on Trump-Era Device Regulation
MedTech Insight
Public Policy & Regulation attorneys John Vaughan, Michael Werner and Sara Klock spoke to MedTech Insight about potential regulatory changes in the medical device industry under the incoming Trump Administration. The attorneys highlighted key areas to watch, including the over-the-counter (OTC) drug user fee negotiations, artificial intelligence (AI) regulation and diagnostics oversight. Mr. Vaughan addressed the challenges in AI regulation, pointing out the inconsistencies in terminology used by various regulatory bodies and the need for a unified approach in the near future.
"There's going to need to be some effort to standardize those sorts of definitions, because if you can't define various forms of AI, it's going to be difficult for them to regulate those forms of AI," he said. "So at some point over the next four years, regulators are going to have to refine their approaches to that taxonomy."
READ: Attorneys Expect OTC Drug User Fee Deal to Shed Light on Trump-Era Device Regulation (Subscription required)
"There's going to need to be some effort to standardize those sorts of definitions, because if you can't define various forms of AI, it's going to be difficult for them to regulate those forms of AI," he said. "So at some point over the next four years, regulators are going to have to refine their approaches to that taxonomy."
READ: Attorneys Expect OTC Drug User Fee Deal to Shed Light on Trump-Era Device Regulation (Subscription required)