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

Article preview from "The Gray Sheet"-  April 2, 2012

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

Article preview from "The Gray Sheet"-  April 2, 2012

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considered during pre-market reviews excludes 510(k)s from its scope after industry objected to inclusion of 510(k)s in draft guidance issued last summer.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 version.

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,” the agency said.

The eagerly awaited guidance outlines the systematic approach FDA device reviewers will take when making risk-benefit determinations and explains the various principal factors to be considered by the agency during device and diagnostic reviews. In particular, the guidance describes an approach that takes into account patients’ tolerance for risks and perspectives on benefits, as well as the novelty of the device.

The first-of-its-kind guidance document “clarifies this process for industry, which will provide manufacturers with greater predictability, consistency and transparency in FDA decision-making while allowing manufacturers and the FDA to use a common framework for benefit-risk determinations,” CDRH Director Jeffrey Shuren said in a statement.

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