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Today, the U.S. Food and Drug Administration (FDA) updated the device shortage list and the device discontinuance list on the web page for Medical Device Shortages During the COVID-19 Public Health Emergency. In addition, the FDA is providing information about devices that have been removed from the device shortage list at this time.
Device Shortage List Updates
The FDA updated the device shortage list to add:
- Automated external defibrillators (AEDs) (product codes MKJ and MVK)
- Chest drains/suction canisters and autotransfusion systems (product codes CAC and KDQ)
The FDA also updated the device shortage list to remove:
- Medical gowns (product codes FME, FYA, and OEA)
- Surgical masks (product code FXX)
More information about how the FDA determines it is appropriate to remove product codes from the device shortage list is available on FDA’s webpage.
Discontinuance List Updates
The FDA added certain discontinued medical devices to the device discontinuance list, including:
- one brand of needles and syringes (product code GAA),
- three brands of surgical masks (product code FXX),
- one brand of gloves (product code LZA),
- one brand of blood collection devices (product code JKA),
- two brands of laboratory equipment (product code LXG), and
- one brand of transport medium (product code QMC).
Questions?
The FDA updated its Supplies of Medical Devices for COVID-19: Frequently Asked Questions web page to provide information about:
- How the FDA determines to remove product codes from the device shortage list and
- What the is FDA doing to help medical device manufacturers with the global shortage of semiconductor chips.
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