The U.S. Food and Drug Administration (FDA) The FDA continues to monitor the healthcare landscape and supply chain for resulting shortages, or meaningful disruptions to U.S. supply, of certain medical devices to help ensure that patients and healthcare providers have timely and continued access to high-quality medical devices to respond effectively to the COVID-19 public health emergency.
The FDA’s 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 COVID-19.
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 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.
