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MDUFMA Part II

The FDA is requesting Congress to reauthorize the Medical Device User Fee and Modernization Act of 2002 (MDUFMA I). In MDUFMA II, the FDA is proposing to increase user fees for processing medical device applications by 31%. That means the industry would end up funding $287 million over the next five years to supplement money appropriated by Congress.

by Robert Neil

Under a proposal that’s likely to be approved by federal lawmakers, the Food and Drug Administration (FDA) will increase future user fees for processing medical device applications by 31%. The planned increase is the inevitable reality of doing business with a government agency that has been overwhelmed and understaffed for a number of years. The good news is the rise in charges manufacturers would have to bear is aimed at making the FDA’s job more realistic in terms of speeding up the approval process

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