> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Encourages Voluntary Device Shortage Notices
- URL: https://www.fdaweb.com/fda-encourages-voluntary-device-shortage-notices/
- Published: 2023-05-12T12:00:00.000Z
- Updated: 2026-09-14T18:31:35.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154443

Now that the Covid-19 public health emergency (PHE) is officially over, FDA is urging medical device makers to maintain the status quo regarding PHE-related authority that required companies to report situations that could lead to device shortages. That authority, Section 506J of the FD&C Act, required manufacturers of certain devices to notify the agency of a permanent discontinuance or an interruption in the manufacture of a device that is likely to lead to a meaningful disruption in domestic supplies of the device. Now that the PHE is over, the mandatory nature of these notifications is no longer in effect.

In a [5/12 notice](https://www.fda.gov/medical-devices/medical-device-safety/medical-device-supply-chain-and-shortages?ref=fdaweb.com), FDA is encouraging device makers to continue to notify it about manufacturing interruptions and discontinuances on a voluntary basis. “The FDA aims to issue draft guidance on voluntary 506J notifications in the near future, as directed by section 2514(b) of the Consolidated Appropriations Act, 2023,” it says.