510(k) Program, Companion Dx Among Top FDA Guidance Priorities For FY 2014

CDRH says it plans to release the 510(k) program final guidance as well as the anticipated in vitro companion diagnostic final guidance next year. The device center has divided the 22 forthcoming guidance documents into an “A-list” and a “B-list,” based on its priorities and allocated resources.

The device center released its guidance priorities for fiscal year 2014; among them are final guidances on the 510(k) program and in vitro companion diagnostics, as well as a draft guidance on benefit-risk determinations in 510(k)s.

As part of the 2012 medical device user fee agreement, FDA was required to keep an updated website

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