FDA Pulls Plug on Four COVID Tests: Time to Switch
Published Date: 5/29/2025
Notice
Summary
The FDA is ending emergency use permissions for four COVID-19 test kits from Pfizer, MAWD Laboratories, and Nuclein (now part of Molecular Diagnostics). This means these specific tests can no longer be used under emergency rules, as the companies asked for it. If you use these tests, check for updates soon—this change could affect testing options but won’t cost you extra.
Analyzed Economic Effects
1 provisions identified: 0 benefits, 1 costs, 0 mixed.
Four COVID-19 Tests Lose Emergency Use
If you use one of these specific COVID-19 tests, they can no longer be used under the Emergency Use Authorization rules: Lucira COVID-19 All-In-One Test Kit; Lucira CHECK-IT COVID-19 Test Kit; MAWD Laboratories SARS-CoV-2 Dual Target by RT-PCR; and DASH SARS-CoV-2/S Test (Nuclein/Molecular Diagnostics). The companies asked the FDA to revoke the authorizations, so these tests may no longer be available under EUA and could change your local testing options, but the notice states this change will not cost you extra.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-12239 — Agency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals
The FDA wants your thoughts on how they collect info about using drugs in animals in ways not originally approved (called extralabel use). This affects vets, farmers, and animal drug makers who report this info. You’ve got until August 17, 2026, to share your comments—no cost changes, just making sure the paperwork is clear and easy.
2026-12237 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles and Medicated Feeds
The FDA is updating how companies that make special animal medicines and feeds keep their records and follow quality rules. This affects manufacturers of Type A medicated articles and medicated feeds, helping ensure safe and reliable products for animals. Comments on these changes are open until July 20, 2026, and the updates aim to keep things clear without adding extra costs.
2026-12245 — Authorization of Emergency Use for Two Animal Drugs for the Prevention and Treatment of New World Screwworm; Availability
The FDA just gave the green light for two new animal drugs to fight the nasty New World screwworm, a bug that harms cattle, horses, pigs, and even exotic animals. These emergency approvals started in April 2026 to help protect U.S. livestock and wildlife quickly. Farmers, vets, and animal lovers can now use these treatments to stop infestations and keep animals safe without delay.
2026-12235 — Advisory Committee; Science Board to the Food and Drug Administration; Renewal
The FDA is renewing its Science Board for two more years, keeping expert advice flowing to help ensure safe and effective drugs and products. This renewal affects scientists and public health folks who guide the FDA’s big decisions, with the new term lasting until June 26, 2028. No extra costs or delays are expected—just more smart brains working for your health!
2026-12238 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
The FDA is asking for public feedback by July 20, 2026, on their rules that keep dietary supplements safe and made right. These rules affect companies that make, package, label, or store supplements, helping ensure products are high quality without adding extra costs. This review keeps the safety standards up-to-date and clear for everyone involved.
2026-12236 — SpecGx LLC; Withdrawal of Approval of Abbreviated New Drug Application for Methylphenidate Hydrochloride Extended-Release Tablets, 27 Milligrams, 36 Milligrams, and 54 Milligrams
SpecGx LLC has asked the FDA to withdraw its approval for three strengths (27 mg, 36 mg, and 54 mg) of its methylphenidate extended-release tablets, effective June 18, 2026. This means these specific versions of the medicine will no longer be allowed on the market. Patients and pharmacies using these doses should look for alternatives, but no extra costs or penalties are mentioned.
Previous / Next Documents
Previous: 2025-09676 — Freedom of Information Act (FOIA) Advisory Committee Meeting
The FOIA Advisory Committee is meeting soon to talk about how to make government information easier to get for everyone. This affects anyone who wants to access public records and could lead to faster, clearer responses from agencies. Stay tuned for updates that might change how and when you get your info, with no extra cost to you!
Next: 2025-09681 — Growing, Harvesting, Processing, and Distribution of Poppy Seeds-Industry Practices Related to Opiate Alkaloids; Request for Information; Extension of Comment Period; Correction
The FDA fixed a mistake in their earlier notice about extending the time to share thoughts on how poppy seeds are grown, processed, and handled, especially concerning opiate chemicals. This update mainly affects farmers, processors, and distributors of poppy seeds who want to weigh in. The comment period is still open, so don’t miss your chance to speak up!