510(k) Program, Companion Dx Among Top FDA Guidance Priorities For FY 2014-thegraysheet: 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fiscal year 2014; among them are final guidances on the 510(k) program and in vitro companion diagnostics, as well as a draft guidance on benefit-risk determinations in 510(k)s. As part of the 2012 medical device user fee agreement, FDA was required to keep an updated website with its guidance priority lists for the upcoming fiscal year. The “A-list” is composed of prioritized device guidance documents FDA plans to publish within the year. Whereas the “B-list” includes guidance documents that FDA plans to publish as resources permit.
