By Jof Enriquez – December 29, 2016
The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has posted the lists of medical device guidance documents it will prioritize for fiscal year 2017, pursuant to the Medical Device User Fee Amendments of 2012 (MDUFA III) (Public Law 112-114).
CDRH provides three lists: (1) a list of guidance documents that the Agency fully intends to publish (the “A-list”); (2) a list of guidance documents that the Agency intends to publish as resources permit (the “B-list”); and (3) a list of final guidance documents issued in 2007, 1997, 1987, and 1977 subject to focused retrospective review, as well as possible revision or withdrawal.
Among the A-list are final guidance documents on medical device cybersecurity, next-generation sequencing-based diagnostic devices, and the use of real-world evidence (RWE) to aid regulatory decision-making. Cybersecurity and RWE also are included in CDRH’s top ten science priorities for 2017, announced in September.
Included in the B-list are final guidance documents on unique device identification (UDI) and investigational device exemption (IDE) categories to support CMS coverage decisions. Also included is the draft guidance on electromagnetic compatibility of electrically powered medical devices, developed with the help of early stakeholder input.
CDRH says it issued 20 of 33 guidances on the FY 2016 list (14 from the A-list, 6 from the B-list). Several guidance documents that were not published in FY 2016, but were deemed high priority through stakeholder feedback, are now on the annual agenda for FY 2017, according to RAPS.
FDA says in a notice in the Federal Register that it welcomes comments on any or all of the guidance documents on the FY 2017 lists, allowing CDRH to better prioritize and more efficiently draft or finalize guidances, and to delete guidance documents that no longer represent the Agency’s interpretation, thinking, or policy on a regulatory issue.