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Today, the U.S. Food and Drug Administration (FDA) issued this final guidance: Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act.
Under section 506J of the FD&C Act, manufacturers are required to notify the FDA, during or in advance of a public health emergency (PHE), of a permanent discontinuance or interruption in the manufacturing of certain devices that is likely to lead to a meaningful disruption in supply of that device in the United States. This guidance provides information about notifications under section 506J during or in advance of any public health emergency.
Facts about the final guidance
This final guidance:
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Helps manufacturers provide timely, informative notifications to prevent or mitigate device shortages.
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Provides the 506J Device List, which specifies devices, by FDA product code, for which a manufacturer of such devices is required to notify the FDA in accordance with section 506J.
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Clarifies that the FDA may receive additional voluntary notifications about medical device supply chain issues at any time, unrelated to the declaration or potential declaration of a PHE.
Upcoming webinar on this guidance
On Tuesday, March 4, 2025, the FDA will host a webinar for those interested in learning more about the guidance.
Questions?
If you have questions about this final guidance, contact the Division of Industry and Consumer Education.
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