Supply and Shortages of Medical Devices: Frequently Asked Questions

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to as the "506J guidance"), and "Select Updates for the 506J Guidance: 506J Device List and Additional Notifications" draft guidance.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.

This page addresses common questions on medical device shortages and notifications under section 506J of the Federal Food, Drug, and Cosmetic (FD&C) Act.

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.

The information provided may be useful to health care facilities and health care personnel, as well as manufacturers.

506J Notification FAQs

Q. Are 506J notifications required now that the COVID-19 public health emergency (PHE) declaration expired?

A. Section 506J of the FD&C Act requires manufacturers of certain devices to notify the 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 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.

On May 11, 2023, the declaration of the public health emergency relating to COVID-19 declared under section 319 of the PHS Act expired. Given the expiration of this public health emergency, the FDA no longer expects that manufacturers continue to submit mandatory 506J notifications for devices that FDA identified as critical to public health during the COVID-19 public health emergency. The 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of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency (Revised), has been withdrawn.

Section 2514 of the Consolidated Appropriations Act, 2023 (P.L. 117-328) clarified the 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.

Q. What is the status of the FDA's guidance documents related to Section 506J?

A. In March 2023, the FDA issued a Federal Register (FR) notice addressing the agency's COVID-19-related guidance documents, including which of those guidance documents will no longer be in effect after the expiration of the COVID-19 public health emergency declared under the Public Health Service (PHS) Act, and which of those guidance documents the FDA is revising to temporarily continue in effect.

As described in the FR notice, the 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 (Revised), was included in the table of Guidance Documents That Will No Longer Be in Effect Upon Expiration of the COVID-19 PHE Declaration. This guidance has been withdrawn.

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 list devices for which the manufacturer is required to notify the FDA in accordance with section 506J.

If you are experiencing an interruption or permanent discontinuance that is not related to a public health emergency, you may not be required to notify the FDA under section 506J of the FD&C Act. However, you may still voluntarily notify the FDA.

Q. How do I submit voluntary 506J notifications?

A. Manufacturers and other stakeholders are encouraged to continue to notify the FDA about manufacturing interruptions and discontinuances on a voluntary basis.

Until the FDA finalizes guidance on this topic, stakeholders may provide such information as they see fit. Device manufacturers are welcome to use the webform to submit a notification. However, if you do not wish to use the webform, manufacturers may also email their information to CDRHManufacturerShortage@fda.hhs.gov and begin the email subject line with the word "Notification."

Other stakeholders are also welcome to notify the FDA directly of supply chain issues and can reach out to the Office of Supply Chain Resilience (OSCR) by emailing deviceshortages@fda.hhs.gov.

For instructions on how to notify the FDA of an interruption or permanent discontinuance in manufacturing:

Submit a 506J Notification

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. This section of the law also directed the FDA to issue draft guidance to facilitate voluntary notifications under section 506J. See the 506J Device List webpage for more information on FDA's guidance documents related to Section 506J.

The FDA has always had the ability to receive voluntary information and has appreciated device manufacturers, distributors, health care providers, and other stakeholders sharing supply chain information, on a voluntary basis, during the COVID-19 public health emergency and prior to the emergence of COVID-19.

Q. Who should submit a notification of an interruption or permanent discontinuance in the manufacturing of a device during a public health emergency?

A. Manufacturers of devices that are critical to public health during a public health emergency, or for which the FDA determines information on potential meaningful supply disruptions is needed, are required to notify the FDA pursuant to section 506J of the FD&C Act 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.

Other stakeholders (patients, healthcare providers, healthcare systems, distributors, group purchasing organizations) experiencing supply chain disruptions may also notify the FDA by emailing: deviceshortages@fda.hhs.gov.

Q. Is the information I submit confidential?

A. Any information provided to the FDA that is trade secret or confidential information will be treated as such, consistent with 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. Please email CDRHManufacturerShortage@fda.hhs.gov and describe the error included in your 506J notification.

Q. What information is required to be submitted in a 506J notification?

A. Section 506J of the FD&C Act requires manufacturers to submit a notification of a permanent discontinuance in the manufacture 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, as well as the reason for such discontinuance or interruption.

In follow-up to a 506J notification, the FDA may seek additional information, on a voluntary basis, to help the FDA prevent or mitigate a shortage or potential shortage of the device.

Q. How do I submit notifications using the webform? Where can I find help if I have trouble using the webform?

A. Please see the Online 506J Notification Submission Methods: Frequently Asked Questions for more information on submitting information through the webform, submitting large numbers of notifications using the spreadsheet, troubleshooting, and finding answers to frequently asked questions on the webform.

Device Shortage List FAQs

Q. How does the FDA determine what devices are in shortage?

A. "Shortage" is defined in section 506J of the FD&C Act 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 reviews each notification under section 506J of the FD&C Act (or "506J notification") it receives, and uses this information, along with additional information on the supply of and demand for the device, to determine whether a device is in shortage. Other information the FDA may consider in making shortage determinations includes, but is not limited to:

Indications of supply disruptions (for example, 506J notifications and additional manufacturer information);
Indications of distribution pressures (for example, from distributors and group purchasing organizations);
Indications of demand or projected demand, such as availability issues reported from users (for example, patients, healthcare providers, hospitals and healthcare facilities, and associations representing these groups);
International factors (for example, export restriction); and
Certain actions taken to help prevent or mitigate shortages including, but not limited to, actions taken by manufacturers, the FDA, or other stakeholders.

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. At this time, the FDA's determination of whether there is adequate supply to meet demand for a specific device category does not take into account the quantity of supplies accrued in the Strategic National Stockpile (SNS).For more information, see Medical Device Shortages List.

Q. How can I view the latest additions to the medical device shortage list?

A. The FDA continues to keep the device shortage list updated. For more information, see Medical Device Shortages List. The blue box above the list provides details on the latest additions to the list as well as any other changes.

Q. How does the FDA determine it is appropriate to remove a product code from the device shortage list?

A. The FDA determines it is appropriate to remove a product code from the device shortage list when the FDA determines the demand or projected demand for the device in the United States no longer exceeds the supply for a sustained period of time. To make this determination, the FDA considers the information used to determine whether a device is in shortage (described above) from a variety of sources, including manufacturers, distributors, health care providers, and group purchasing organizations.

If the FDA has determined that it is appropriate to remove a product code from the device shortage list, but you are experiencing a discontinuance, interruption, or disruption in the availability of a device associated with that product code:

Manufacturers of the device should submit a 506J notification. The information the FDA receives in notifications under Section 506J of the FD&C Act assists the FDA in preventing or mitigating shortages of such devices, helping to prevent negative impacts to patients and healthcare personnel;
Distributors, health care facilities and providers, and other stakeholders may email the FDA at deviceshortages@fda.hhs.gov. This information can also help assist FDA in preventing or mitigating device shortages.

Q. What device product codes has the FDA determined are appropriate to remove from the device shortage list?

A. The FDA updated the device shortage list to remove:

Medical gloves (product codes LYY, LYZ, LZA, and LZC) on December 12, 2022
Surgical respirators (product code MSH) on August 26, 2022
Medical gowns (product codes FME, FYA, and OEA) on July 19, 2022
Surgical masks (product code FXX) on July 19, 2022
MRI breast biopsy grid plate related devices on June 8, 2023:
- Coil, Magnetic Resonance, Specialty, MRI breast biopsy grid plate only (product code MOS)
- Breast Biopsy / Localization Tray, MRI breast biopsy grid plate only (product code PXP)
- Guide, Needle, Surgical, MRI breast biopsy grid plate only (product code GDF)
Testing Supplies and Equipment on July 14, 2023:
- Tubes, vials, systems, serum separators, blood collection (product code JKA)
- Tubes, vacuum sample, with anticoagulant (product code GIM)
- Absorbent tipped applicator (product code KXG)
- Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents (product code QOF)
- Micro pipette (product code JRC)
- Equipment, laboratory, general purposes, labeled or promoted specifically for medical use, pipette tips only (product code LXG)
- General purpose reagents for in vitro diagnostic tests, including pipette tips (product code PPM)
- Instrumentation for clinical multiplex test system (product code NSU)
- Real time nucleic acid amplification system (product code OOI)
- Clinical sample concentrator (product code JJH)
- Culture Media, Non-propagating (product code JSM)
- Microbiological specimen collection and transport device (product code LIO)
- Microbial nucleic acid storage and stabilization device (product code QBD)
Saline, Vascular Access Flush (product code: NGT)
Certain Ventilation-Related Products on July 14, 2023:
- Non-continuous ventilator (product code BZD)
- Ventilator, Continuous, Minimal Ventilatory Support, Facility Use (produce code MNT)
- Ventilator, Continuous, Non-Life-Supporting (product code MNS)

In times when 506J notifications are not required, the FDA has more limited information about potential disruptions in the domestic supply of critical devices and has more limited ability to determine the extent and duration of shortages of critical devices. For more information on how the FDA determines shortages visit Medical Device Supply Chain and Shortages.

Q. Since the FDA has removed the surgical mask and surgical respirator product codes from the device shortage list, will the related emergency use authorizations (EUAs) be revoked?

A: The removal of a product code from the device shortages list is distinct from and does not impact the existing EUAs. These EUAs remain in effect at this time.

Q. What is the FDA doing to help medical device manufacturers with the global shortage of semiconductor chips?

A. There is a global shortage of semiconductor chips. These computer chips are essential building blocks for many products, including some medical devices. The FDA continues to work with federal partners and other stakeholders to help mitigate challenges associated with semiconductor shortages. In addition, the FDA has issued guidance documents to help provide clarity when a change in a medical device might trigger the requirement that a manufacturer submit a new premarket submission to the FDA, including:

If you are experiencing supply issues for a medical device related to the global semiconductor shortage, you may contact the FDA about a medical device supply chain issue. This information supports the FDA's shortage analysis that informs measures the FDA may be able use to help address device supply availability.

Q. Are there additional resources to consult if I cannot find supplies of the devices on the Device Shortage List?

A. For health care providers and other stakeholders seeking information on acquiring assets from the Strategic National Stockpile (SNS), refer to the request SNS assets web page. Contact Regional Emergency Coordinators (RECs) for assistance to request personal protective equipment (PPE), ventilators, medical countermeasures, and federal medical station needs.

To mitigate ongoing shortages, the U.S. government continues to take actions, including providing information about alternatives. To assist stakeholders, the FDA posted the following resources:

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 categories of devices the FDA has determined to be in shortage at this time and will continue to be updated. A shortage refers to a period of time when the U.S. demand or projected demand for the device exceeds the supply; however, the FDA recognizes there may be regional supply interruptions or other challenges obtaining a particular device, even if the total U.S. demand does not exceed the supply.

Distributors, health care facilities and providers, and other stakeholders may email the FDA at deviceshortages@fda.hhs.gov. This information can also help assist FDA in preventing or mitigating device shortages.

Q. What does the FDA do with information about medical device shortages?

A. The analysis of information related to the permanent discontinuance and interruptions in the manufacture of certain devices informs the FDA's work to help mitigate and prevent device shortages, including issuance of Emergency Use Authorizations (EUAs) for products that play an important role in meeting demand. Certain devices currently available in the United States may only be available under an EUA, which requires, among other things, that there be no adequate, approved, and available alternatives.

For more information, see Fact Sheet: Mitigating and Preventing Medical Device Shortages and Prioritizing Public Health.

Contacts

Q. Who can I contact if I have additional questions?

A. Contact the FDA with questions about a medical device supply chain issue.

U.S. Food and Drug Administration