FDA Issues Final Guidance On Device Shortage Reporting, Adds Device List

 
• By Brian Bossetta

The US FDA has published final guidance requiring firms to notify the agency about significant manufacturing interruptions of medical devices during a public health emergency, as well as a supplementary draft guidance that includes a list of specific devices that manufacturers must report to the agency when they are in short supply.

Respirators Needed
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The US Food and Drug Administration has published final guidance it says will help manufacturers provide timely and vital information about production changes of medical devices that can reduce shortages of those devices during a public health emergency (PHE).

The final document, “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act,” published on 17 November, updates the draft guidance the agency issued during the COVID-19 pandemic and seeks to

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