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The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday released a list of 12 final guidance documents and four draft guidances that it will make a priority to publish in FY 2017.
The final guidance documents on the so-called “A-list” deal with some hot-button issues, including the use of real world evidence (which is also included on CDRH’s top 10 list of science priorities for 2017) to support medical device regulatory decisions, as well as device cybersecurity and next generation sequencing-based diagnostic devices.
CDRH also released a list (known as the “B-list”) of five final guidance topics and eight draft guidance topics that the agency hopes to publish, resources permitting.
In review of FY 2016, 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 on the FY 2016 lists that were not published within FY 2016 are now on the annual agenda for FY 2017.
These lists were released as part of FDA’s obligations under the Medical Device User Fee Amendments of 2012 (MDUFA III), as outlined in Thursday’s Federal Register:
Final Guidance Topics
Draft Guidance Topics
Tags: CDRH, draft guidance for medical devices, device manufacturer guidance from FDA