A. Section 506J of the FD&C Act requires manufacturers of certain devices to notify the FDA of a permanent discontinuance or an interruption in the manufacture of a device that is likely to lead to a meaningful disruption in domestic supply of the device during, or in advance of, a public health emergency declared 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.

On May 11, 2023, the declaration of the public health emergency relating to COVID-19 declared under section 319 of the PHS Act expired. Given the expiration of this public health emergency, the FDA no longer expects that manufacturers continue to submit mandatory 506J notifications for devices that FDA identified as critical to public health during the COVID-19 public health emergency. The 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of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency (Revised), has been withdrawn.

Section 2514 of the Consolidated Appropriations Act, 2023 (P.L. 117-328) clarified the 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.