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FDAnews Device Daily Bulletin

CDRH Details Processes Used for Deficiencies, Appeals

Oct. 6, 2017

CDRH has issued final guidance for industry and agency staff on how to deal with deficiencies the agency identifies when reviewing device marketing applications.

Under MDUFA IV, the FDA committed to updating the guidance to state that all deficiency letters issued by the agency will include a statement of the basis for the deficiencies, as well as the specific scientific or regulatory issue.

The agency also committed to conducting a supervisory review of each deficiency letter to ensure that all cited deficiencies are relevant to the authorization decision.

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