FDA Greenlights More Emergency Devices for Ongoing COVID Fight
Published Date: 1/21/2026
Notice
Summary
The FDA just gave the green light for certain medical devices to be used during the COVID-19 emergency. This means doctors and hospitals can use these devices faster to help fight the virus, keeping everyone safer. These authorizations started as soon as they were issued, making sure help arrives right when it’s needed most.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
EUA reissue for LumiraDx antigen test
The FDA re‑issued an Emergency Use Authorization for the LumiraDx SARS‑CoV‑2 Ag Test on June 10, 2025, allowing its emergency use to diagnose COVID‑19. The notice says the authorization is effective on its date of issuance and that FDA concluded the test may be effective for diagnosing COVID‑19 and that no adequate, approved, and available alternative exists.
EUAs for multianalyte COVID/Flu tests
The FDA authorized multianalyte tests that detect SARS‑CoV‑2 and influenza A/B: Aptitude Medical Systems Inc.'s Metrix COVID/Flu Test was issued on February 21, 2025, and Healgen Scientific LLC's Healgen COVID‑19/Flu A&B Ag Combo Rapid Test Cassette (Swab) was issued on June 10, 2024. These EUAs say the tests may be effective for simultaneous detection and differentiation of SARS‑CoV‑2 and influenza and are effective on their issuance dates.
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.
2026-17215, Evaluation of Therapeutic Equivalence; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Evaluation of Therapeutic Equivalence." This guidance explains FDA's thinking on therapeutic equivalence evaluations and therapeutic equivalence codes (TE codes). FDA's therapeutic equivalence evaluations are listed for multisource prescription drug products approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the active section of the "Approved Drug Products With Therapeutic Equivalence Evaluations" (commonly known as the Orange Book). These therapeutic equivalence evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of health care costs. This guidance finalizes the draft guidance of the same title issued in July 2022.
2026-17229, Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 066
The Food and Drug Administration (FDA or the Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled "Modifications to the List of Recognized Standards, Recognition List Number: 066" (Recognition List Number: 066), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
2026-17222, Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry titled "Bioequivalence Recommendations for Specific Products" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance.
Previous / Next Documents
Previous: 2026-01068, Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints To Support Accelerated Approval; Draft Guidance for Industry; Availability
The FDA is rolling out new draft guidance to help drug makers use special tests called minimal residual disease (MRD) and complete response (CR) to speed up approval of multiple myeloma treatments. This means patients with this blood cancer could get access to promising drugs faster. Industry folks should send their feedback by March 23, 2026, so the FDA can finalize the rules and keep innovation moving without unnecessary delays.
Next: 2026-01071, New Postal Products
The Postal Service wants to add or change special deals for competitive mail services, and the Postal Regulatory Commission is asking the public to share their thoughts by January 26, 2026. This affects businesses and customers who use these special mail options, with no immediate price changes announced. It’s a chance to weigh in on new or updated mail products that could shake up how competitive mail works.