AdvaMed Floats Legislation To Allow User-Fee Submissions During Shutdowns

25 Jan 2019

As the partial US government shutdown enters its second month, the backlog of device pre-market applications is building. AdvaMed is proposing language that would allow FDA to accept and review new user-fee-funded submissions during government shutdowns.

Applications for new devices and diagnostics have stalled at US FDA, which is blocked from accepting and reviewing any new submission that requires user fees until the ongoing partial government shutdown is over. AdvaMed is floating legislation that would allow user-fee-funded submissions to come through regardless of political stalemates.

As the US government shutdown continues into its 34th day, the device industry says it is starting to feel more...