FDA releases proposals to update device approval process

08/3/2010 | Wall Street Journal, The

The FDA on Tuesday released a set of proposals with the aim of clarifying which devices can use the 510(k) approval process and when medical evidence is mandatory for approval. Advanced Medical Technology Association President and CEO Stephen J. Ubl said the recommendations "could result in a significant disruption to a program that has served patients well for more than 30 years." The agency is also proposing a Class IIb category of devices, which would include drug infusion pumps.

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