Congress
Passes, President Signs Legislative Measure to Extend User Fee Program
MDUFSA
On August 1, President Bush signed the Medical Device User Fee Stabilization
Act (MDUFSA) a bill that extends the medical device user fee program through
federal fiscal year 2007 and:
· Increases the small business threshold for payment of user fees
to $100 million from $30 million in annual sales for PMAs, PMA Supplements
and 510(k)s – Companies submitting their first PMA, with revenues
less than $30 million still receive user fee waiver.
· Mandates full funding of CDRH by Congress.
· Requires reprocessers to label single-use devices
· Places a cap on the annual device user fee increase at 8.5%
Senator Edward Kennedy played a key role in assuring the bill’s
swift passage prior to Congressional recess. Without this action, the
user fee program would have expired due to funding shortfalls caused by
lack of Congressional appropriations.
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