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.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-20281, Global Benchmark for Efficient Drug Pricing (GLOBE) Model
Starting November 30, 2026, Medicare will use the new GLOBE Model to help lower the cost of certain drugs for people on Original Medicare. This model changes how drug price increases are calculated, aiming to save money for both patients and the Medicare program without cutting care quality. If you’re on Medicare Part B, expect smarter drug pricing that helps keep your healthcare affordable.
2026-20131, Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2027 and Updates to the IRF Quality Reporting Program; Correction
This correction fixes some technical mistakes in the Medicare payment rules for inpatient rehab facilities starting October 1, 2026. It mainly affects hospitals and rehab centers by clarifying how wage data and payments are calculated, ensuring fairer payment rates for fiscal year 2027. No big changes in money, but it keeps everything accurate and on track.
2026-20067, Medicare Program; FY 2027 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements; Correction
This correction fixes some technical mistakes in the FY 2027 hospice payment and wage index rules that were first published in August 2026. It mainly affects hospice providers by updating how their payments are calculated, making sure the numbers are accurate starting October 1, 2026. These changes help ensure hospices get the right payment amounts based on the latest hospital wage data.
2026-19959, Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program for Federal Fiscal Year 2027; Correction
This correction fixes some technical mistakes in Medicare payment rules for skilled nursing facilities starting October 1, 2026. It mainly affects how hospital data is used to calculate payments, making sure no current hospitals are wrongly excluded. These tweaks help keep Medicare payments fair and accurate for providers and patients.
2026-19946, Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2027 Rates; Requirements for Quality Programs; Other Policy Changes; and Adoption of Updated Versions of Certain Health Information Technology Standards; Correction
This update fixes some typos and technical mistakes in the Medicare payment rules for hospitals starting October 1, 2026. It affects hospitals getting paid for patient care, making sure the payment system and quality programs run smoothly. These corrections help hospitals get the right payments and follow updated health tech standards without delays or confusion.
2026-19493, Patient Protection and Affordable Care Act; Temporary Moratoria on Certain Agent and Broker Registration To Participate in the Exchanges
Starting now, new agents and brokers without a 2026 registration can’t sign up to help people enroll in health insurance through federal exchanges for 2027. This pause helps stop fraud and protect your info while CMS improves safety rules. If you’re already registered or working with state exchanges, this doesn’t affect you.
Previous / Next Documents
Previous: 2026-13369, Submission for Office of Management and Budget Review; Office of Refugee Resettlement Annual Survey of Refugees
The Office of Refugee Resettlement wants to keep running its Annual Survey of Refugees through 2027 without changing the questions right now. This survey helps the government understand and support refugee families who arrived in the last five years. They’re asking for public feedback by August 3, 2026, and plan to improve the survey later based on new online testing.
Next: 2026-13374, Termination of Declaration Authorizing Emergency Use of Drug and Biological Products During the COVID-19 Pandemic
The U.S. Department of Health and Human Services is ending the special emergency rules that allowed quick use of COVID-19 drugs and vaccines. This change affects companies, healthcare workers, and patients who relied on these emergency approvals. The emergency use authorization will officially stop on June 29, 2027, giving everyone time to adjust without sudden disruptions or extra costs.