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  6. Medical Device Shortages During the COVID-19 Public Health Emergency
  1. Coronavirus (COVID-19) and Medical Devices

Medical Device Shortages During the COVID-19 Public Health Emergency

During the COVID-19 public health emergency (PHE), the FDA has taken many actions to help ensure that patients and health care providers have timely and continued access to high-quality medical devices to respond effectively to the COVID-19 public health emergency. These actions include issuing Emergency Use Authorizations (EUAs) and guidance documents to provide recommendations and help expand the availability and capability for various diagnostic, therapeutic, and protective medical devices in high demand during the COVID-19 public health emergency.

On March 27, 2020, the CARES Act was signed into law. Section 3121 of the CARES Act amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding section 506J to the statute. Section 506J provides the FDA -- for the first time -- with authority intended to help prevent or mitigate medical device shortages "during, or in advance of, a public health emergency declared by the Secretary under section 319 of the PHS Act." The provision includes requirements for manufacturers of certain devices to notify the FDA "of a permanent discontinuance in the manufacture of the device" or "an interruption in the manufacture of the device that is likely to lead to a meaningful disruption in supply of that device in the United States" during a declared public health emergency.

One provision of this new statutory authority -- section 506J(g) of the FD&C Act -- requires the FDA to 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 list of medical devices for which the FDA has been notified that manufacturing has been permanently discontinued. The list below fulfills this statutory obligation and reflects the categories of devices the FDA has determined to be in shortage at this time, and will be maintained and updated as the COVID-19 public health emergency evolves.*

The FDA publishes this device shortages list to provide transparency to the American public, particularly those who use and/or purchase medical devices. The presence of a device type on this list does not necessarily indicate that patient care has been affected.

How FDA Determines What Devices Are In Shortage

In determining whether a product should be included on the public list, FDA carefully reviews each 506J notification it receives.  

In addition, the analysis of information related to potential device shortages informs FDA work related to other measures 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 are only 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 FDA's consideration of additional mechanisms for addressing device supply availability, including providing enforcement discretion, and working with other federal partners.

FDA's determination of whether to include a device category on this shortage list did not take into account supplies accrued in the Strategic National Stockpile.  FDA anticipates that Defense Production Act (DPA) investments made since March 2020 will begin to relieve observed supply pressures as they enter medical device distribution channels in the coming months.  For healthcare providers and other stakeholders seeking information on acquiring assets from the Strategic National Stockpile, please refer to the SNS request page.

Manufacturers of device types that are included on this list should review section 506J of the FD&C Act, as well as other parts of 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 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 Agency 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.

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Device Shortage List

Categories of devices in the device shortage list are:

  • Personal Protective Equipment
  • Testing Supplies and Equipment
  • Ventilation-Related Products
Date Posted Category Product Code Reason for Interruption Estimated Shortage Duration Additional Information
08/14/2020 Personal Protective Equipment FME (Examination gown) Demand increase for the device Duration of COVID-19 PHE Availability: Limited supply
08/14/2020 Personal Protective Equipment FXX (Surgical apparel) Demand increase for the device;
Delay in shipping of the device;
Shortage or discontinuance of a component or part
Duration of COVID-19 PHE Availability: Limited supply
08/14/2020 Personal Protective Equipment FYA (Surgical gown) Demand increase for the device Duration of COVID-19 PHE Availability: Limited supply
08/14/2020 Personal Protective Equipment LYY (Latex, non-powdered patient examination glove) Demand increase for the device Duration of COVID-19 PHE Availability: Limited supply
08/14/2020 Personal Protective Equipment LYZ (Vinyl patient examination glove) Demand increase for the device Duration of COVID-19 PHE Availability: Limited supply
08/14/2020 Personal Protective Equipment LZA (Polymer, non-powdered patient examination glove) Demand increase for the device Duration of COVID-19 PHE

Availability: Limited supply

Product code LZA includes nitrile gloves

08/14/2020 Personal Protective Equipment LZC (Specialty, non-powdered patient examination glove) Demand increase for the device Duration of COVID-19 PHE

Availability: Limited supply

Product code LZC includes nitrile gloves

08/14/2020 Personal Protective Equipment MSH (Surgical respirator) Demand increase for the device Duration of COVID-19 PHE Availability: Limited supply
08/14/2020 Personal Protective Equipment OEA (Non-surgical isolation gown) Demand increase for the device Duration of COVID-19 PHE

Availability: Limited supply

Level 2 Gowns Only

08/14/2020 Testing Supplies and Equipment JJH (Clinical sample concentrator) Demand increase for the device Duration of COVID-19 PHE Availability: Limited supply
08/14/2020 Testing Supplies and Equipment JSM (Transport culture medium) Demand increase for the device Duration of COVID-19 PHE Availability: Limited supply
08/14/2020 Testing Supplies and Equipment KXG (Sterile swabs) Demand increase for the device Duration of COVID-19 PHE Availability: Limited supply
08/14/2020 Testing Supplies and Equipment LIO (Microbiological specimen collection and transport device) Demand increase for the device Duration of COVID-19 PHE Availability: Limited supply
08/14/2020 Testing Supplies and Equipment NSU (Instrumentation for clinical multiplex test systems) Demand increase for the device Duration of COVID-19 PHE Availability: Limited supply
08/14/2020 Testing Supplies and Equipment OOI (Real time nucleic acid amplification system) Demand increase for the device Duration of COVID-19 PHE Availability: Limited supply
08/14/2020 Testing Supplies and Equipment PPM (General purpose reagents for in vitro diagnostic tests) Demand increase for the device Duration of COVID-19 PHE Availability: Limited supply
08/14/2020 Testing Supplies and Equipment QBD (Microbial nucleic acid storage and stabilization device) Demand increase for the device Duration of COVID-19 PHE Availability: Limited supply
08/14/2020 Ventilation-Related Products BZD (Non-continuous ventilator) Demand increase for the device Duration of COVID-19 PHE Availability: Limited supply
08/14/2020 Ventilation-Related Products CBK (Continuous ventilator, facility use) Demand increase for the device Duration of COVID-19 PHE Availability: Limited supply
08/14/2020 Ventilation-Related Products NOU (Continuous ventilator, home use) Demand increase for the device Duration of COVID-19 PHE Availability: Limited supply

* FDA has determined, pursuant to section 506J(g)(3)(C) of the FD&C Act (titled "Public Health Exception"), that disclosure of the manufacturer's name of the devices determined to be in shortage during the COVID-19 PHE  will adversely affect the public health by increasing the potential for hoarding or other disruptions in device availability to patients.

Discontinuance List

As part of the list required pursuant to section 506J(g) of the FD&C Act, the FDA is providing a separate, publicly-available, up-to-date list of the devices for which the FDA has been informed by the manufacturer have been discontinued.  The FDA will update this list when it receives additional information regarding device discontinuances.

Categories of devices in the discontinuance list are:

  • Infusion Pumps and Related Accessories
  • Vital Sign Monitoring
Date Posted Category Product Code Manufacturer Name Device Trade Name Reason for Discontinuance
09/24/2020 Vital Sign Monitoring MSX (Cardiac monitor, including cardiotachometer and rate alarm) Philips Medical Systems IntelliSpace Event Management Discontinuance of the manufacture of the device (to be permanently discontinued on December 31, 2020)
 08/14/2020 Infusion Pumps and Related Accessories

FRN (Infusion Pump)

MEA (Infusion Pump, Patient Controlled Analgesic))

Becton Dickinson and Company (CME America, LLC)

BodyGuard Infusion Pump System

BodyGuard Syringe Pump System, BodyGuard microsets

Shortage or discontinuance of a component or part;

Discontinuance of the manufacture of the device;

Facility closure
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