Manufacturing Industry
Medical device stabilization act to speed approval of new technology.(MPMD)
Advanced Materials & Processes, October, 2005
Following approval in the U.S. House of Representatives and the Senate, the Medical Device User Fee and Stabilization Act (MDUFSA) was passed in a move to help smaller medical device companies afford the costs to submit new medical devices for FDA review and approval. The legislation is designed to make key changes to the FDA's Medical Device User Fee and Modernization Act program that has allowed companies to get life-saving medical devices to patients in a timely manner.
Once enacted, the legislation will raise the FDA's threshold for small businesses from $30 million in annual sales to $100 million, increasing the number of small businesses eligible to pay substantially reduced fee rates, thereby encouraging them to continue their work on innovative medical...
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