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FDA Subject To More Oversight Following User Fee Bill Passage

The legislation, awaiting the signature of the president, will bring greater scrutiny of device center activities by Congress and industry.

The precise impact of the FDA legislation that passed Congress last week remains to be seen. But it does appear likely that the law will facilitate greater scrutiny by Congress and industry of the agency’s device review performance and policy development.

The legislation will result in detailed performance reporting requirements for FDA’s pre-market device program. It also requires an independent assessment...

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