Top Lobbyist: User Fee Deal Should Focus On Agreements Already In Place
In an exclusive and wide-ranging interview with Medtech Insight, Mark Leahey, president of the Medical Device Manufacturers Association, said the previous four Medical Device User Fee negotiations with the FDA have set a strong foundation for the industry and the next round of negotiations should focus on tweaking past deals that are already in place.
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Regulators, industry, patient advocates and other stakeholders will meet at the US agency's headquarters on 7 April to discuss priorities for the next round of medical device user-fee negotiations.
CDRH’s Shuren Talks MDUFA, Industry’s Premarket Wants, Emerging Technologies, And More In Wide-Ranging Interview
In an exclusive interview with Medtech Insight, FDA device center director Jeff Shuren said the agency will possibly discuss issues such as postmarket surveillance and patient engagement in upcoming MDUFA negotiations. He also talked about some recent big wins for the agency and his vision for the coming year.
The top official on artificial intelligence products at the US FDA says that while the agency has some authorities to implement regulatory oversight, it may need additional powers from Congress considering the direction the FDA may possibly take in regulating AI and machine learning products.