QUOTED. April 12, 2019. Anonymous.
The US FDA wants to put a list online of devices using predicates more than a decade old as a way to discourage the use of older predicates, which may rely on outdated science. Device-makers are balking, while others – like one anonymous artificial hip patient – want even more action. See what that person said here.
“The FDA needs to shut down the entire 510(k) process, or get a handle on the biggest violators and culprits who are abusing the system for financial gain only. After three revisions, two dislocations and one ‘infection,’ I am pretty certain that something went way south here.” – Anonymous Artificial Hip Patient
- Find out more: Industry Gets Extra Month For 510(k) Revamp Comments
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