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Medical Device Supply Chain and Shortages

Update: January 6, 2025

The FDA has issued a final guidance document: “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act.” 

The final guidance addresses section 506J of the FD&C Act, as it relates to notifying the FDA, during or in advance of a public health emergency, of a permanent discontinuance or interruption in the manufacturing of certain devices that is likely to lead to a meaningful disruption in the domestic supply of that device. This guidance represents the Agency's current thinking on this topic.

This guidance also provides a list of devices (the 506J Device List), by FDA product code, for which a manufacturer of such devices is required to notify the FDA in accordance with section 506J. The guidance also clarifies that the FDA may receive additional voluntary notifications regarding supply chain issues at any time, unrelated to the declaration or potential declaration of a public health emergency.

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 (PHEs), and discontinuations.

The Office of Supply Chain Resilience (OSCR), in the CDRH Office of Strategic Partnerships & Technology Innovation (OST), is responsible for managing the FDA's activities to anticipate and prevent disruptions to supply chains for medical devices. OSCR is also responsible for maintaining an up-to-date medical device shortage list.

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

Section 506J of the FD&C Act requires manufacturers of certain devices to notify the FDA, during or in advance of a public health emergency (declared under section 319 of the Public Health Service Act), of a permanent discontinuance or an interruption in the manufacture of a device that is likely to lead to a meaningful disruption in domestic supply of the device. 

Section 506J(h) also clarifies that the FDA may receive voluntary notifications pertaining to the permanent discontinuance or interruption in the manufacture of a device at any time, unrelated to the declaration of a PHE.

The FDA's final guidance, "Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act," represents the Agency's current thinking on this topic. The final guidance also includes the 506J Device List, a list of medical devices, by the FDA product code, for which the manufacturer is required to notify the FDA in accordance with section 506J.

Although 506J notifications are not required outside of a PHE, the FDA encourages device manufacturers 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.

Notifying the FDA about Device Supply Chain Availability Issues

For information on how to notify the FDA of an interruption or permanent discontinuance in manufacturing that is likely to lead to a shortage visit Notify the FDA About an Interruption or Permanent Discontinuance in Device Manufacturing (506J Notification).

The FDA is also interested in hearing from health care facilities and providers that may be having difficulty obtaining medical devices, as well as from other interested parties who may be impacted by potential shortages. Please email the FDA at deviceshortages@fda.hhs.gov.

Lists of Device Shortages and Discontinued Devices

For the most up-to-date medical device shortage list, visit the Medical Device Shortages List web page.  

For recent device discontinuances, visit the device discontinuance list.

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