AdvaMed Floats Legislation To Allow User-Fee Submissions During Shutdowns
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.
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US FDA has about three months' worth of medical device carryover user-fee funds to burn if the partial federal government shutdown continues, although the agency is still finalizing its shutdown balance sheet, Commissioner Scott Gottlieb says.
Bolus of applications could be filed once government reopens, but employee morale and recruitment efforts could suffer drop-off.
A 2014 omnibus appropriations bill passed by the House Jan. 15 and the Senate a day later would give FDA $2.55 billion in discretionary funding, a $91 million increase. In news applauded by the device industry, the bill would also make available $85 million in previously sequestered FDA user fees. President Obama was expected to quickly sign the bill before a Jan. 18 midnight deadline to prevent a government shutdown.