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Medical Device Supply Chain and Shortages

Update: November 16, 2023

The FDA issued the following guidances: "Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act" final guidance (hereafter referred to as the "506J Guidance"), and "Select Updates for the 506J Guidance: 506J Device List and Additional Notifications" draft guidance. For more information, visit the 506J Device List webpage.

For questions about the medical device supply chain and shortages, see Supply and Shortages of Medical Devices: Frequently Asked Questions.

Shortages of medical devices can occur for many reasons, including manufacturing and quality problems, geopolitical issues, natural disasters, delays, public health emergencies, and discontinuations.

The Office of Supply Chain Resilience (OSCR) is responsible for managing the FDA's activities to anticipate and prevent disruptions to the supply chain for medical devices, including maintaining the medical device shortage list.

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FDA's Device Shortage Authority Under Section 506J of the FD&C Act

On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law. The CARES Act added Section 506J to the Federal Food, Drug, and Cosmetic Act (FD&C Act), which requires manufacturers to notify the FDA about a permanent discontinuance or interruption in manufacturing likely to lead to a meaningful disruption in the domestic supply of certain devices "during, or in advance of, a public health emergency declared by the Secretary under section 319 of the Public Health Service (PHS) Act."

By statute, the mandatory nature of these "506J notifications" applies only during or in advance of a declared public health emergency. Therefore, given that the COVID-19 public health emergency expired on May 11, 2023, the FDA no longer expects that manufacturers continue to submit 506J notifications for devices that FDA identified as critical to public health during the COVID-19 public health emergency. Section 2514 of the Consolidated Appropriations Act, 2023 (P.L. 117-328) clarified FDA's authority to receive voluntary notifications from manufacturers of certain devices outside of declared public health emergencies.

The FDA encourages device manufacturers to continue to notify the FDA about manufacturing interruptions and discontinuances on a voluntary basis, as such information is essential to our efforts to help prevent and mitigate disruptions in the supply of critical devices. The FDA aims to issue draft guidance on voluntary 506J notifications in the near future, as directed by section 2514(b) of the Consolidated Appropriations Act, 2023.

Guidance Documents Regarding Section 506J of the FD&C Act

In November 2023 , the FDA issued the following guidances: "Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act" final guidance (hereafter referred to as the "506J Guidance"), and "Select Updates for the 506J Guidance: 506J Device List and Additional Notifications" draft guidance.

The 506J Guidance addresses section 506J of the 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.

When finalized, the FDA's draft guidance, "Select Updates for the 506J Guidance: 506J Device List and Additional Notifications," will represent the FDA's current thinking on the guidance "Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act." Specifically, this draft guidance includes the 506J Device List that, when finalized, will serve as the list for which a manufacturer of such devices is required to notify the FDA in accordance with section 506J.

Previously, the FDA issued an immediately in effect guidance, Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff. This guidance, which has been withdrawn, was intended to assist manufacturers in providing the FDA timely, informative notifications about changes in the production of certain medical devices that could help the Agency prevent or mitigate shortages of such devices during the COVID-19 public health emergency.

Notifying the FDA about Device Supply Chain Availability Issues

For instructions on how to notify the FDA of an interruption or permanent discontinuance in manufacturing during a public health emergency (under Section 506J of the FD&C Act):

Submit a 506J Notification

The FDA is interested in hearing from health care facilities and providers having trouble obtaining medical devices, as well as from other stakeholders who may be able to help mitigate potential shortages. Notify the FDA about a medical device supply issue.

Lists of Device Shortages and Discontinued Devices

For an up-to-date list of devices that the FDA has determined to be in shortage in the United States, refer to Medical Device Shortages List. Section 506J(g) of the FD&C Act requires the FDA to establish and maintain a publicly available, up-to-date list of the devices the FDA has determined to be in shortage.

In addition, the FDA is providing a device discontinuance list of medical devices for which the FDA has been notified that manufacturing has been permanently discontinued.

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