The Food and Drug Administration (FDA) has made available a final guidance document titled "Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act." This guidance updates a previous version and includes a list known as the 506J Device List, which outlines device product codes that manufacturers must notify the FDA about if they stop production. The document clarifies that manufacturers can also voluntarily notify the FDA of any supply chain issues, regardless of public health emergencies. This guidance aims to facilitate continuous device supply and prevent shortages.
Simple Explanation
The FDA wants to make sure there are enough medical devices available, so they made a rule that if a company stops making certain important devices, they have to tell the FDA. Even if there are no emergencies, companies can let the FDA know if they have problems making enough devices to help prevent shortages.