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FDA’s Final Risk-Benefit Guidance Excludes 510(k)s, Adds De Novo Petitions

Device center reviewers will begin applying the guidance to incoming PMA and de novo submissions and to submissions already under review with decisions beginning on May 1.

FDA’s final guidance describing how the risks and benefits of devices are considered during pre-market reviews excludes 510(k)s from its scope after industry objected to inclusion of 510(k)s in draft guidance issued last summer.

Released March 27, the final guidance also includes information on risk-benefit determinations for de novo classification petitions that was not included in the August 2011 draft...

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