(Released 20 August 2020) 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.
On this page:
Related pages:
- Medical Device Supply Chain Notifications During the COVID-19 Public Health Emergency
- Medical Device Types to Help Determine Section 506J Notification Obligations
- Contact the FDA About a Medical Device Supply Chain Issue
Device Shortage List
Categories of devices in the device shortage list are:
- Personal Protective Equipment
- Testing Supplies and Equipment
- Ventilation-Related Products
Released by the U.S Food & Drug & Administration. Click here for source.