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Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices: Guidance for Industry and Food and Drug Administration Staff

FinalCenter for Devices and Radiological Health Center for Biologics Evaluation and Research11/03/2023

Description

FDA is issuing this guidance to make minor updates to align with section 3304 of the Consolidated Appropriations Act, 2023, Pub. L. No. 117-32, which directs FDA to provide certification for devices that are not exported from the United States (CFG-NEs). This guidance describes the information that the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER), in collaboration with the Office of Regulatory Affairs (ORA), will provide to a person whose request for a Certificate to Foreign Government (CFG) for a device is denied, and the process for seeking review of such a denial. The updated guidance explains that the processes referenced in the guidance apply to CFG-NEs as well as CFGs, pursuant to FD&C Act section 801(e)(4)(F)(iv), unless otherwise specified.

Scope & Applicability

Product Classes

2
Class II Recall

Grounds for denial of export certificate

Class I Recall

Grounds for denial of export certificate

Stakeholders

2
Owner, operator, or agent in charge

Persons to whom the PCHF requirements apply; Responsible for determining hazards requiring preventive controls; Person responsible for determining hazards requiring preventive control

Manufacturer

Entity responsible for submitting NDINs

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