Medical device companies are pressing the FDA to speed up its review process before it is given reauthorization to collect user fees in 2012, according to a report by MedCity.
Congress initially gave the FDA authority to collect user fees in 2002, to help reverse the agency's resource shortfall and speed up the review process. The program was reauthorized in 2007, but before a next reauthorization occurs in 2012, device-makers want the FDA to meet goals to speed up reviews.
In return for receiving the fees, the FDA has been given specified performance goals, involving benchmarks for measuring improvements in review times. Under a proposal for the 2012 reauthorization, device companies would continue to pay user fees at current levels plus a 4 percent inflationary increase each year.
Read the MedCity report on medical device companies.
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