MDUFMA recognizes that “the public health will be served” by providing additional funds to FDA for “the process for the review of devices and the assurance of device safety and effectiveness so that statutorily mandated deadlines may be met.” FDA’s medical device program resources have been reduced in recent years, and there have been indications that review performance has begun to decline. The user fees provided by MDUFMA, and the additional appropriations that go with the new law, will provide significant benefits: - Safe and effective medical devices will reach patients more rapidly.
- Greater certainty that manufacturers will receive timely, high-quality reviews.
- Resources to ensure that devices marketed in the United States continue to meet high standards for safety and effectiveness.jfdalk dsiqrwepoi rewqrq;p[iorew[q alfdsk;lkfds;lfdsak'
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