The U.S. Food and Drug Administration (FDA) recently expanded its medical device shortage list to include all blood sample collection tubes, a list designed to help ensure healthcare professionals are more knowledgeable about available medical devices
Prior to the expansion of blood sample collection listing in January 2022, the FDA last year issued a letter to health care and laboratory personnel specifically about a shortage of sodium citrate blood specimen collection tubes. The FDA’s list also includes a section on devices that have been discontinued
The FDA’s entire device shortage list of categories includes dialysis-related products; personal protective equipment (PPE); testing supplies and equipment; and ventilation-related products. Meanwhile, its discontinuance list of categories includes general ICU/hospital products; infusion pumps and related accessories; orthopedics; sterilization products; and vital sign monitoring, among others.
The FDA publishes the device shortages list to provide transparency to the 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 FDA says.
Information on Section 506J of the FD&C Act
On March 27, 2020, the CARES Act was signed into law. Section 3121 of the CARES Act amended 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 establish and 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.