Medical Device Supply Chain and Shortages
May 12, 2023, Update: Section 506J of the FD&C Act requires manufacturers of certain devices to notify FDA 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 during, or in advance of, a public health emergency declared by the Secretary under section 319 of the Public Health Service 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 The FDA aims to issue draft guidance on voluntary 506J notifications in the near future, as directed by section 2514(b) of the Consolidated Appropriations Act, 2023.
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 Resilient Supply Chain Program (RSCP) 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.
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."
The FDA issued a draft guidance, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act, to assist stakeholders in the FDA's implementation of section 506J of the FD&C Act outside of the COVID-19 public health emergency, and will serve as the baseline for information about notifications under section 506J of the FD&C Act during or in advance of any public health emergency.
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.
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.
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.
05/12/2023May 12, 2023, Update draft guidance