Postmarket Surveillance Activity Linked To Device User Fee Proposal

The possibility of medical device user fees eventually funding CDRH postmarket surveillance activity is raised in a provision of the "Medical Device User Fee & Modernizaton Act" of 2002

More from Archive

More from Medtech Insight

Execs On The Move: June 23–27, 2025

 
• By 

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.

Court Orders US FDA To Return Trial Diversity Action Plan Guidance To Website

 
• By 

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.

Planning To Take Part in MDUFA? FDA Wants To Hear From You

 

The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.