Industry trade association AdvaMed said Wednesday it applauds a bill introduced into the U.S. House of Representatives that would protect FDA user fees from sequestering cuts.
User fees
FDA cuts fiscal 2015 user fees
The FDA is cutting the user fees paid by medical device companies for the watchdog agency’s review by some 3% across the board for fiscal 2015.
The FDA’s Center for Devices & Radiological Health said today that it proposes to cut the fees for both small businesses making less that $100 million annually and for their larger brethren.
FDA’s medical device user fee collections rose 50% last year
AdvaMed lauds user fee return, new funding for FDA | MassDevice.com On Call
MASSDEVICE ON CALL — Medtech industry lobbying group AdvaMed offered high praise for the federal government’s 2014 omnibus appropriations legislation, which restored important funding for the FDA.
The bill returned to the agency about $85 million in collected user fees that had been locked away due to the federal sequester, funds that medical device and drug companies pay for applications for FDA review.
FDA’s lost $85 million in users fees so far due to sequestration, OMB says
Federal officials confirmed this week that the government shutdown and budget sequester had drained some $85 million from the FDA’s coffers, all from the fees that medical device and pharmaceutical companies pay directly to the agency.
Shutdown ends, FDA user fees begin
The FDA can begin collecting user fees from medical device companies for fiscal 2014 now that the federal shutdown is over.
The watchdog agency announced new rates for the fees in August, but couldn’t begin collecting them when the fiscal year began Oct. 1 because of the shutdown that began that day.
Government shutdown: What of FDA’s October meetings?
With the ongoing government shutdown, the FDA is likely to have increasing trouble meeting its commitments, according to medical device industry analysts at GlobalData. That spells trouble for companies such that are scheduled for FDA panel meetings in coming weeks, and it could "spook" investors, GlobalData warned.
FDA proposes fiscal 2014 user fee rates
The FDA wants to raise the user fees paid by medical device companies for the watchdog agency’s review by 4.2% across the board.
The FDA’s Center for Devices & Radiological Health said today that it proposes to boost the fees for both small businesses making less that $100 million annually and for their larger brethren.
The increases would cover applications for 510(k) clearance, the more stringent pre-market approval process and a raft of other applications to the FDA.