FDA Finally Axes Three COVID Tests' Emergency Status
Published Date: 3/20/2025
Notice
Summary
The FDA is officially ending the emergency use of three COVID-19 antibody tests made by Beckman Coulter, effective January 8, 2025. This change affects anyone using these specific tests for COVID-19 detection and diagnosis. The company requested this revocation, so no extra costs or disruptions are expected for users.
Analyzed Economic Effects
2 provisions identified: 0 benefits, 2 costs, 0 mixed.
Three Beckman Coulter COVID-19 Tests Revoked
The FDA revoked the Emergency Use Authorizations for Beckman Coulter's Access SARS-CoV-2 IgG, Access SARS-CoV-2 IgM, and Access SARS-CoV-2 IgG II tests effective January 8, 2025. If you or your doctor used these specific tests for COVID-19 detection or diagnosis, those EUAs are no longer in effect as of that date. The company requested the revocations, and the notice states no extra costs or disruptions are expected for users.
Beckman Coulter Stopped Distributing Tests Jan 1, 2025
Beckman Coulter notified FDA that it would discontinue distribution of the Access SARS-CoV-2 IgG, Access SARS-CoV-2 IgM, and Access SARS-CoV-2 IgG II tests as of January 1, 2025 and requested revocation on November 22, 2024. As a result, laboratories, clinics, and other providers that used these tests will no longer receive them after January 1, 2025.
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
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2025-04978, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA is delaying a new rule about nonprescription drugs that have extra conditions for use. Originally set to start on March 21, 2025, the rule’s start date is now pushed back to May 27, 2025, to allow more time for review. This affects drug makers and consumers by giving everyone extra time to prepare for the new requirements without any immediate cost changes.
2025-01840, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA’s new rule about nonprescription drugs needing extra conditions before use was set to start on January 27, 2025, but it’s now delayed until March 21, 2025. This delay follows a presidential order to pause and review new rules before they take effect. Drug makers, sellers, and consumers should note the new start date and get ready for the updated rules soon.
2026-20727, Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections Using Home-Collected Specimens
The FDA is officially classifying home test kits that detect non-viral germs causing sexually transmitted infections as Class II devices, meaning they have special safety rules but fewer hurdles than the strictest category. This change, effective October 9, 2026, helps make these tests safer and easier to get, benefiting patients and innovators alike. If you make or use these home test kits, this update means better access and clear safety standards without extra costs or delays.
Previous / Next Documents
Previous: 2025-04709, Meeting of the Advisory Committee
The Advisory Committee on Actuarial Examinations will hold a closed teleconference on April 25, 2025, to discuss new topics for future actuarial exams. This affects actuaries preparing for enrollment exams, with potential changes to exam content but no immediate cost or deadline changes announced. The meeting is private to protect sensitive exam details.
Next: 2025-04711, Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 063
The FDA just updated its official list of standards that medical device makers can use to prove their products are safe and effective. These changes take effect on March 20, 2025, helping companies speed up their approval process without extra costs. If you’re in the medical device world, this means clearer rules and smoother reviews starting soon!