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Guidance Issuing OfficeCenter for Devices and Radiological HealthCenter 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 added by section 3121 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), Pub. L. No. 116-136 (March 2020), as it relates to notifying FDA 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 during or in advance of a public health emergency (PHE).
FDA plays a critical role in protecting the United States from threats, such as emerging infectious diseases, and other PHEs. Section 506J requires manufacturers to notify FDA, during or in advance of a PHE, of a permanent discontinuance in the manufacture of certain devices or an interruption in the manufacture of certain devices that is likely to lead to a meaningful disruption in supply of that device in the United States. This guidance is intended to assist manufacturers in providing timely, informative notifications about changes in the production of certain medical devices that will help prevent or mitigate shortages of such devices. This guidance also recommends that manufacturers voluntarily provide additional information to better ensure FDA has the specific information it needs to help prevent or mitigate shortages during or in advance of a PHE.
FDA is issuing this guidance to assist stakeholders in the Agency’s 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2022-D-0053.