2023-25458: Notifying the Food and Drug Administration of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act; Final Guidance for Industry and Food and Drug Administration Staff; and Select Updates for the 506J Guidance: 506J Device List and Additional Notifications; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of the final guidance entitled "Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act" and the draft guidance entitled "Select Updates for the 506J Guidance: 506J Device List and Additional Notifications." The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires manufacturers to notify FDA of a permanent discontinuance 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 during or in advance of a public health emergency (PHE). This final guidance is intended to assist manufacturers in providing timely, informative notifications about changes in the production of certain medical device products that will help prevent or mitigate shortages of such devices. FDA is concurrently issuing a draft guidance to propose select updates to the final guidance "Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act." This draft guidance proposes a list of device product codes for which a manufacturer of such devices is required to notify FDA in accordance with the FD&C Act (hereafter referred to as the "506J Device List") and clarifies that manufacturers may submit voluntary notifications regarding supply chain issues at any time, unrelated to the declaration or potential declaration of a PHE. This draft guidance is not final nor is it for implementation at this time.

The agency’s own summary, as published.