FDA Encourages Voluntary Device Shortage Notices

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 Now that the PHE is over, the mandatory nature of these notifications is no longer in effect.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, 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 “The FDA aims to issue draft guidance on voluntary 506J notifications in the near future, as directed by section 2514(b) of the Consolidated Appropriations Act, 2023,” it says.