Supplies of Medical Devices for COVID-19: Frequently Asked Questions

December 12, 2022 Update: The FDA updated the question, What device product codes has the FDA determined it is appropriate to remove from the device shortage list?, and added the question, Since the FDA has removed medical gloves from the device shortage list, will the related enforcement policy be revoked?

This page responds to common questions on medical device shortages and notifications under section 506J of the Federal Food, Drug, and Cosmetic (FD&C) Act during the COVID-19 pandemic.

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

506J Notification FAQs

Q. Who should submit a notice of an interruption or permanent discontinuance in the manufacturing of a product during the COVID-19 Public Health Emergency?

A. Manufacturers of certain 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 during a public health emergency, 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 devices. Manufacturers should review section 506J of the FD&C Act, as well as other parts of the FDA's 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) - Immediately in Effect Guidance for Industry and Food and Drug Administration Staff, to determine whether they are required to notify the FDA under section 506J of the FD&C Act. 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 during the COVID-19 public health emergency, helping to prevent negative impacts to patients and healthcare personnel.

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. If there are no changes to the situation, do I need to submit an updated notification?

A. At this time, the FDA recommends that manufacturers provide updates every six weeks until the issue has been resolved, even if the status remains unchanged. These updates help ensure that the FDA can act on the most current information.

Q. What if some devices are experiencing an interruption and other devices are not?

A. Manufacturers must submit 506J notifications during or in advance of a Public Health Emergency for certain devices that they manufacture that are experiencing an interruption or permanent discontinuance likely to lead to a meaningful disruption in the supply of the device in the United States, as discussed in more detail in the FDA's 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).

If a manufacturer is not experiencing an interruption or permanent discontinuance, they are not required to notify the FDA under section 506J of the FD&C Act. However, they may voluntarily provide this information to the FDA.

If a manufacturer is experiencing an interruption or permanent discontinuance of a device that is not related to the COVID-19 PHE, they are not required to notify the FDA under section 506J of the FD&C Act. However, manufacturers may voluntarily provide this information to the FDA.

Providing voluntary information to the FDA can help the Agency better understand the supply chain landscape and device availability, in turn helping the FDA to work to mitigate or prevent shortages.

Q. I realized I submitted incorrect information. How can I correct or change a notification I previously submitted?

A. Please email [email protected] and describe the error included in your 506J notification.

Q. If I have an interruption or permanent discontinuance that is not related to the public health emergency, can I still notify the FDA about this information?

A. If you are experiencing an interruption or permanent discontinuance that is not related to the public health emergency, you may not be required to notify the FDA under section 506J of the FD&C Act. However, if you would still like to voluntarily notify the FDA, you may submit that information using either the webform or spreadsheet.

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

A. Section 506J of the FD&C Act requires manufacturers to notify the Secretary of a permanent discontinuance in the manufacture of certain devices 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. Please refer to 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), for more information about 506J notifications.

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, troubleshooting, and answers to frequently asked questions on the webform.

Q. How do I submit large numbers of notifications using the spreadsheet? Where can I find help if I have trouble entering information in the spreadsheet?

Device Shortage List FAQs

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

A. "Shortage" is defined in section 506J(i)(2) 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 voluntary 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, health care providers, hospitals, nursing homes, 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 intends to consider 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 During the COVID-19 Public Health Emergency.

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, and group purchasing organizations.

If 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 during the COVID-19 public health emergency, helping to prevent negative impacts to patients and healthcare personnel;
Distributors, health care facilities and providers, and other stakeholders may email the FDA at [email protected]. This information can also help assist FDA in preventing or mitigating device shortages.

Q. What device product codes has the FDA determined it is 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

The FDA will continue to monitor the supply chain and update the list as new information becomes available.

Q. Since the FDA has removed medical gloves and gowns from the device shortage list, will the related enforcement policy be revoked?

A: The removal of medical gloves (product codes LYY, LYZ, LZA, and LZC) and gowns (product codes FME, FYA, and OEA) from the device shortages list does not impact the existing Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency. The policy remains in effect at this time.

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) and enforcement policy be revoked?

A: The removal of surgical masks (product code FXX) and surgical respirators (product code MSH) from the device shortages list does not impact the existing Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency, Umbrella EUA for surgical masks, or NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency. The policy and 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, including enforcement policies, regarding circumstances where manufacturers may consider modifying their devices because of supply chain issues, such as semiconductor supply challenges.

See COVID-19-Related Guidance Documents, including:

Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, which the FDA updated in May 2022:
- The updated version clarifies the examples of circumstances—including changes made to microchips or other associated circuitry and/or software changes—where the FDA currently believes a modification would generally not create an undue risk in light of the public health emergency, and that may be needed to address current manufacturing limitations or supply chain issues due to COVID-19 related disruptions.

The FDA has also issued other 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 be updated as the COVID-19 public health emergency (PHE) evolves.

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:

Distributors, health care facilities and providers, and other stakeholders may email the FDA at [email protected]. This information can also help assist the 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 potential device shortages informs the FDA's work related to other measures the FDA uses to help address the public health emergency, including issuance of Emergency Use Authorizations (EUAs) for products that play an important role in meeting demand. Certain products currently available in the United States during the COVID-19 public health emergency may only be available under an EUA, which requires, among other things, that there be no adequate, approved, and available alternatives.

The analysis of information related to potential device shortages also informs the FDA's consideration of additional mechanisms for addressing device supply availability, including expedited inspections, expedited reviews, and working with other federal partners.

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. If you have questions about 506J notifications, you may email [email protected] and begin the email subject line with the word "Question" to expedite our response to your questions.

For general questions about the availability of medical devices, you may email [email protected].

U.S. Food and Drug Administration

Supplies of Medical Devices for COVID-19: Frequently Asked Questions

On this page:

506J Notification FAQs

Device Shortage List FAQs

Contacts