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CDRH Offers Primer On Its Guidance Priority-Setting Process

The device center’s priorities for guidance development shift throughout the year based on evolving urgencies and mandates, and are not fully reflected on the public website. CDRH described its process at a meeting this month, and heard guidance wish lists for industry and other stakeholders.

CDRH annually prioritizes about one-third of the guidance documents it hopes to get out quickly and continuously analyzes its own progress. Nonetheless, limited resources and congressional input means that not all prioritized documents will be issued before the fiscal year ends, a device center policy official says.

Phil Desjardin, associate director for policy at CDRH, discussed the center’s priority-setting process and, with other FDA managers, took feedback from industry and advocacy groups during a meeting held earlier...

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