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# Device Discontinuance Notification Guidance
- URL: https://www.fdaweb.com/device-discontinuance-notification-guidance/
- Published: 2020-05-06T12:00:00.000Z
- Updated: 2026-09-14T16:13:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146731

FDA has issued an immediately-in-effect guidance, *Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act During the Covid-19 Public Health Emergency*, to implement the medical device notification requirement that was included in the recent Coronavirus Aid, Relief, and Economic Security Act. The [document](https://www.fda.gov/media/137712/download?ref=fdaweb.com) says the provision requires medical device manufacturers to notify the agency of a permanent discontinuance in the manufacture of certain devices or an interruption in the manufacture of certain devices that is likely to lead to a meaningful disruption in the supply of that device in the U.S.

The guidance is intended to assist manufacturers in providing FDA timely, informative notifications about changes in the production of certain medical device products that will help the agency prevent or mitigate the shortage of such devices during the Covid-19 public health emergency.

FDA says the policy is intended to remain in effect only for the duration of the HHS public health emergency.