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# 3 MDUFA 4 Guidances Issued
- URL: https://www.fdaweb.com/3-mdufa-4-guidances-issued/
- Published: 2017-10-03T12:00:00.000Z
- Updated: 2026-09-14T22:53:54.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139767

FDA has issued three guidances based on the just-approved MDUFA 4 reauthorization giving the effect on the FDA review clock and goals of agency and industry actions on [510(k) submissions](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationsandGuidance/GuidanceDocuments/UCM089738.pdf?ref=fdaweb.com), [PMAs approvals](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationsandGuidance/GuidanceDocuments/UCM089734.pdf?ref=fdaweb.com), and [*de novo* classification requests](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationsandGuidance/GuidanceDocuments/UCM576305.pdf?ref=fdaweb.com). In each instance, the guidance details performance goals that were established during the MDUFA 4 negotiations and covers actions that FDA may take on such requests, the effect each action has on performance goals, and industry actions that can be taken.