 
Today, the U.S. Food and Drug Administration (FDA) issued the final guidance: Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act (“506J Guidance”). The FDA is issuing this guidance to address section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as it relates to notifying the FDA of a permanent discontinuance or interruption in the manufacturing of certain devices likely to lead to a meaningful disruption in the domestic supply of that device during, or in advance of, a public health emergency (PHE).
The FDA is also issuing the draft guidance: Select Updates for the 506J Guidance: 506J Device List and Additional Notifications. This draft guidance provides information to facilitate voluntary notifications on supply chain issues at any time, unrelated to the declaration or potential declaration of a PHE. The Select Update also 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 (“506J Device List”). The FDA intends to incorporate the updates proposed in this draft guidance into the 506J Guidance as one final guidance document after obtaining and considering public comment on these proposed select updates.
Today, the FDA also announced plans to convene an Advisory Committee on February 6, 2024, to discuss medical device supply chain resiliency and device shortages issues, including the 506J Device List. Please refer to the federal register for information regarding the Advisory Committee. The FDA set up a docket for public comment on this Advisory Committee meeting. The docket number is FDA-2023-N-4807.
Submit comments on the draft guidance
The Agency invites comments on the draft guidance, including the 506J Device List and the clarifications related to voluntary notifications. Submit comments under docket number FDA-2022-D-0053 at https://www.regulations.gov by February 15, 2024 to ensure the FDA considers comments on this draft guidance before it begins work on the final version of the guidance.
Questions?
If you have questions about these guidances, contact the Division of Industry and Consumer Education.
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