FDA Ends Emergency Use for COVID Medical Devices
Published Date: 7/2/2026
Notice
Summary
The U.S. Department of Health and Human Services is ending the emergency use authorizations for certain COVID-19 medical devices, including tests and masks, on December 26, 2026. This change affects manufacturers, healthcare providers, and anyone using these devices, signaling a return to normal rules and regulations. No emergency use means these products will now follow regular approval processes, with no extra emergency funding involved.
Analyzed Economic Effects
3 provisions identified: 0 benefits, 2 costs, 1 mixed.
Manufacturers Must Seek Regular Approval
FDA and HHS are encouraging manufacturers of EUA-authorized COVID-19 tests, personal respiratory protective devices, and other medical devices to obtain authorization through traditional premarket/marketing pathways and to begin transition planning. FDA issued final guidance in March 2023 and HHS is providing 180 days advance notice before termination, with the declarations ending on December 26, 2026.
EUA Termination for COVID-19 Devices
The Department of Health and Human Services is terminating three emergency-use declarations for (1) in vitro diagnostic COVID-19 tests, (2) personal respiratory protective devices (masks), and (3) certain medical devices on December 26, 2026. This affects manufacturers, healthcare providers, and anyone using those devices because they will no longer be covered by the emergency authorizations.
No Emergency Funding; Product Disposition Rules
HHS states there will be no extra emergency funding tied to these EUAs and that, if an EUA ceases to be effective, HHS/FDA will consult with manufacturers about appropriate disposition or return of unapproved products. The notice also functions as the required 180-day advance notice before the December 26, 2026 termination.
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Key Dates
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