The U.S. Food and Drug Administration is aggressively pursuing the creation of a national evaluation system for medical devices designed to generate better evidence for more efficient device evaluation and clinical/regulatory decision making.
As the cost of bringing new medical devices to market has become increasingly expensive and time-consuming, threatening to hamper innovation, FDA officials say the planned National Device Evaluation System (NDES) would help make safe and effective devices available to patients and their physicians more quickly as well as post-market information on which the agency can make more informed regulatory decisions. In particular, by leveraging real-world evidence, they contend that a national medical device evaluation system would strike the right balance between pre-market and post-market data collection.
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