On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law. The CARES Act added Section 506J to the Federal Food, Drug, and Cosmetic Act (FD&C Act), which requires manufacturers to notify the FDA about a permanent discontinuance or interruption in manufacturing likely to lead to a meaningful disruption in the domestic supply of certain devices "during, or in advance of, a public health emergency declared by the Secretary under section 319 of the Public Health Service (PHS) Act."

By statute, the mandatory nature of these "506J notifications" applies only during or in advance of a declared public health emergency. Therefore, given that the COVID-19 public health emergency expired on May 11, 2023, the FDA no longer expects that manufacturers continue to submit 506J notifications for devices that FDA identified as critical to public health during the COVID-19 public health emergency. Section 2514 of the Consolidated Appropriations Act, 2023 (P.L. 117-328) clarified FDA's authority to receive voluntary notifications from manufacturers of certain devices outside of declared public health emergencies.

The FDA encourages device manufacturers to continue to notify the FDA about manufacturing interruptions and discontinuances on a voluntary basis, as such information is essential to our efforts to help prevent and mitigate disruptions in the supply of critical devices. The FDA aims to issue draft guidance on voluntary 506J notifications in the near future, as directed by section 2514(b) of the Consolidated Appropriations Act, 2023.