Sen. Patty Murray said she doesn’t want more uncertainty about user fees during the COVID-19 pandemic and will move to get all the user fees renewed before they expire in September.
The chair of the Senate Health, Energy, Labor and Pensions (HELP) Committee tells Medtech Insight she’s disappointed that the Medical Device User Fee Amendments (MDUFA V) was not included in the package of user fees submitted to the US Congress for approval.
“I'm disappointed we haven't received the proposed medical device user fee agreements yet,” Sen. Patty Murray, D-WA, said. “The medical...
Create an account to read this article
Already a subscriber?
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
Researchers at Johns Hopkins have used a robotic system to autonomously perform a key part of gallbladder surgery without a surgeon's hand. Lead author Axel Krieger says it could take five to 10 years before an autonomous robotic system will reach human trials and expects regulatory hurdles.
“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.
