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GUIDANCE DOCUMENT

Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act Guidance for Industry and Food and Drug Administration Staff January 2025

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2022-D-0053
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA or Agency) is issuing this guidance to address section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as it relates to notifying FDA, during or in advance of a public health emergency (PHE), of a permanent discontinuance or interruption in the manufacturing of a device that is likely to lead to a meaningful disruption in the supply of that device.

This guidance is intended to assist interested parties in the implementation of section 506J. This guidance serves as the baseline for information about notifications under section 506J (hereafter referred to as “506J notifications”) during or in advance of any PHE. If FDA determines it is appropriate, we may issue individual, PHE-specific updates as appendices to this guidance or individual, PHE-specific guidance documents, among other potential options. Such decisions will be made on a case-by-case basis and will be determined by the specific situation and informational need.

This guidance includes a list of devices, by FDA product code, for which a manufacturer of such devices is required to notify FDA in accordance with section 506J of the FD&C Act (hereafter referred to as the “506J Device List”). Additionally, FDA has clarified that manufacturers may submit, and FDA may receive, voluntary notifications regarding supply chain issues at any time, unrelated to the declaration or potential declaration of a public health emergency.

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All written comments should be identified with this document's docket number: FDA-2022-D-0053.

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