Supply and Shortages of Medical Devices: Frequently Asked Questions
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.
Information about devices that are in shortage, experiencing manufacturing disruptions, and being discontinued may be useful to health care facilities, health care personnel, and medical device manufacturers.
On this page:
506J Notification FAQs
Q. When are 506J notifications required?
A. Section 506J of the Federal Food, Drug, and Cosmetic (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. In addition, section 506J(h) 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.
On January 6, 2025, the FDA published 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 guidance represents the Agency's current thinking on this topic. The final guidance also includes the 506J Device List: a list that identifies devices, by the FDA product code, for which medical device manufacturers are required to notify the FDA in accordance with section 506J.
Q. Who is required to submit a notification of an interruption or permanent discontinuance in the manufacturing of a device during, or in advance of, a public health emergency?
A. Pursuant to section 506J of the FD&C Act, manufacturers of devices on the 506J Device List are required to notify the FDA, during or in advance of a public health emergency, of a permanent discontinuance or interruption in manufacturing of such device that is likely to lead to a meaningful disruption in the domestic supply of that device.
When notification is not required by the statute, manufacturers are encouraged, on a voluntary basis, to notify the FDA about medical device supply issues, including manufacturing interruptions and discontinuances.
Other interested parties (patients, health care providers, health care systems, distributors, group purchasing organizations) experiencing supply chain disruptions are encouraged to notify the FDA by emailing: deviceshortages@fda.hhs.gov.
Q. How do I submit 506J notifications?
A. The FDA’s website, “Notify the FDA About a Medical Device Supply Issue,” contains the most current information about submitting 506J notifications to the FDA as well as a way for manufacturers to electronically submit 506J notifications. The FDA has developed an online webform to assist manufacturers in submitting 506J notifications. If you do not wish to use the webform, manufacturers may also email their information to CDRHManufacturerShortage@fda.hhs.gov. If emailing the information, begin the email subject line with the word "Notification." Other interested parties are encouraged to notify the FDA about supply chain issues by emailing deviceshortages@fda.hhs.gov.
Instructions on how to notify the FDA of an interruption or permanent discontinuance in manufacturing are provided in Notify the FDA About an Interruption or Permanent Discontinuance in Device Manufacturing (506J Notification) (salesforce-sites.com).
Q. Is the information I submit to the FDA confidential?
A. Any information provided to the FDA that is confidential or trade secret will be treated as such, consistent with the requirements and obligations set forth in the Freedom of Information Act (FOIA) and disclosure laws. See 5 USC 552(b)(4), 18 USC 1905, and other applicable laws.
Q. I realized I submitted incorrect information. How can I correct or change a notification I previously submitted?
A. Email CDRHManufacturerShortage@fda.hhs.gov with a description of the change or error included in your 506J notification and include your notification number (provided to you upon submission) in the subject line of the email. For devices regulated by CBER contact cbershortage@fda.hhs.gov
Q. What information is required to be submitted in a 506J notification?
A. Section 506J(a) of the FD&C Act requires manufacturers of devices on the 506J Device List to submit notifications of :
- a permanent discontinuance in the manufacture of the device (except for discontinuances as a result of an approved modification of the device); or
- an interruption of the manufacture of the device that is likely to lead to a meaningful disruption in the supply of that device in the United States; and
- the reasons for such discontinuance or interruption.
Additional information can be found on FDA’s website, Notify the FDA About an Interruption or Permanent Discontinuance in Device Manufacturing (506J Notification).
Device Shortage List FAQs
Q. How does the FDA determine what devices are in shortage?
A. Section 506J(j)(2) of the FD&C Act defines “shortage” to mean “a period of time when the demand or projected demand for the device within the United States exceeds the supply of the device.” The FDA carefully reviews each 506J notification we receive and uses this information, along with additional information on the supply and demand of the device, to determine whether a device is in shortage. Other information that the FDA continuously reviews in making shortage determinations includes, but is not limited to:
- Indications of supply disruptions (such as 506J notifications and additional manufacturer information);
- Indications of distribution pressures (such as from distributors and group purchasing organizations);
- Indications of demand or projected demand, such as availability issues reported from users (including patients, health care providers, hospitals and health care facilities, and associations representing these groups);
- International factors (such as export restriction); and
- Certain actions taken to prevent or mitigate shortages including, but not limited to, actions taken by manufacturers, the FDA, or other interested parties (such as a manufacturer placing a product on allocation).
In determining whether a medical device is in shortage, the FDA considers the entirety of relevant and reliable information and data available to the Agency at the time of a decision. For more information, see Medical Device Shortages List.
Q. How can I view the latest additions to the medical device shortage list?
A. 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 determined to be in shortage (Device Shortage List). This list is available on the FDA’s website, Medical Device Shortages List. The latest additions to and removals from the shortage list are often highlighted in the blue box immediately preceding the list.
Q. How often is the medical device shortage list updated?
The Device Shortage List fulfills FDA’s statutory obligation under section 506J(g) of the FD&C Act to maintain a publicly available, up-to-date list of the devices that have been determined to be in shortage. The list is maintained and updated as information relating to a shortage evolves. In determining if a medical device is in shortage, the FDA considers the entirety of relevant and reliable information and data available to the FDA at the time of the decision.
This list also identifies medical devices for which there has been notification that manufacturing has been permanently discontinued ("a discontinuance"). The FDA intends to continue to maintain an up-to-date device shortages list to provide transparency to the American public, based on the information available.
Q. I can't obtain a specific type of product such as a specific model, and it is not on this list. Why isn't the device on this list?
A. The Device Shortage List reflects the product codes of devices the FDA has determined to be in shortage at the current time. The Device Shortage List is updated as new information becomes available. section 506J(j)(2) defines shortage as “a period of time when the demand or projected demand for the device within the United States exceeds the supply of the device.” The FDA also recognizes that regional supply interruptions do occur, and that local shortages or interruptions in a device can result in negative impacts to health care delivery. When experiencing these disruptions, health care providers and other interested parties are encouraged to report medical device shortages to the deviceshortages@fda.hhs.gov mailbox.
Q. What does the FDA do with information about medical device shortages?
A. The FDA uses the information provided in 506J notifications, along with other internal and external data sources, to perform impact assessments that are used to:
- determine if a medical device is in shortage or if a shortage is imminent;
- assess potential impacts to patients and health care delivery in the U.S.; and
- inform types and necessity of implementing regulatory and non-regulatory mitigation strategies (e.g., enforcement discretion, expedited premarket review)
The Office of Supply Chain Resilience (OSCR), in the CDRH Office of Strategic Partnerships and Technology Innovation (OST), is responsible for managing the FDA's activities to anticipate and prevent disruptions in supply chains for medical devices as well as maintaining an up-to-date medical device shortage list.
More information is provided in Fact Sheet: Mitigating and Preventing Medical Device Shortages and Prioritizing Public Health.
Contact
If you have questions, email deviceshortages@fda.hhs.gov.