The FDA published a Fact Sheet: Mitigating and Preventing Medical Device Shortages and Prioritizing Public Health. The fact sheet includes additional information on the FDA’s medical device shortages authority and work on device shortages undertaken in the FDA’s Center for Devices and Radiological Health (CDRH), including actions and lessons learned during the COVID-19 public health emergency.
During the COVID-19 public health emergency, the FDA has taken many actions to help ensure that patients and healthcare providers have timely and continued access to high-quality medical devices to respond effectively. 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.
The FDA publishes a device shortage list to provide transparency to the American public, particularly those who use or purchase medical devices. The list fulfills a statutory obligation under section 506J of the FD&C Act 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 presence of a device type on this list does not necessarily indicate that patient care has been affected.
For healthcare providers and other stakeholders seeking information on acquiring assets from the Strategic National Stockpile (SNS), refer to Requesting SNS Assets. Contact Regional Emergency Coordinators (RECs) for assistance to request personal protective equipment (PPE), ventilators, medical countermeasures, and federal medical station needs.