COVID-19-related guidance documents update | FDA permits marketing of first COVID-19 antigen test using traditional premarket review process

Public health emergency response and other updates from FDA since our last MCMi email include:

• March 14, 2023: FDA Authorizes Bivalent Pfizer-BioNTech COVID-19 Vaccine as Booster Dose for Certain Children 6 Months through 4 Years of Age
• March 14, 2023: FDA Roundup including a COVID-19 vaccine update (see below for more)
• March 14, 2023: Know Your Treatment Options for COVID-19 (updated)
• March 13, 2023: CDER Conversation – The Latest in Drug Shortages
• March 13, 2023: Expanded Access with Dr. Jacqueline Corrigan-Curay (Q&A with FDA podcast and transcript)
• March 9, 2023: FDA Roundup including a notice addressing the agency’s COVID-19-related guidance documents, including which of those guidance documents will no longer be in effect after the expiration of the COVID-19 public health emergency (PHE) declared under the Public Health Service (PHS) Act, and which of those guidance documents the FDA is revising to temporarily continue in effect
• March 8, 2023: Do the COVID-19 vaccines make people more susceptible to emerging COVID-19 variants? (new video)
• March 8, 2023: FDA Permits Marketing of First COVID-19 Antigen Test Using Traditional Premarket Review Process

Quick links: COVID-19 updates from FDA, FDA Mpox Response 

How COVID-19-related guidances will be impacted by the expiration of the COVID-19 public health emergency

FDA issued a notice addressing the agency’s COVID-19-related guidance documents, including which of those guidance documents will no longer be in effect after the expiration of the COVID-19 public health emergency (PHE) declared under the Public Health Service (PHS) Act, and which of those guidance documents FDA is revising to temporarily continue in effect. 

This notice follows an announcement from the U.S. Department of Health and Human Services that, based on current COVID-19 trends, the Department is planning for the COVID-19 PHE declared under the PHS Act to expire on May 11, 2023.

Since the start of the COVID-19 PHE [declared under the PHS Act], FDA has been committed to providing timely recommendations and regulatory information to support response efforts.

During the COVID-19 PHE declared under the PHS Act, FDA has provided important tools and flexibilities to manufacturers, health care facilities, providers, patients, and other stakeholders. 

Importantly, the ending of the PHE declared by HHS under the PHS Act will not impact the FDA’s ability to authorize devices (including tests), treatments or vaccines for emergency use. Existing Emergency Use Authorizations (EUAs) for products will remain in effect and the agency may continue to issue new EUAs going forward when criteria for issuance are met.

FDA remains committed to providing notice and information to all impacted stakeholders to ensure a smooth transition. (March 10, 2023)

FDA authorizes bivalent Pfizer-BioNTech COVID-19 Vaccine as booster dose for certain children 6 months through 4 years of age

FDA amended the EUA of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide for a single booster dose of the vaccine in children 6 months through 4 years of age at least 2 months after completion of primary vaccination with three doses of the monovalent (single strain) Pfizer-BioNTech COVID-19 Vaccine. Learn more (March 14, 2023)

Updated vaccine information

Additional recent COVID-19 vaccine updates include:

• FDA revised the Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (PDF) to include a warning conveying that reports of adverse events following use of the vaccine under EUA suggest increased risks of myocarditis and pericarditis, particularly within the period 0 through 7 days following vaccination. The Fact Sheet for Recipients and Caregivers (PDF) was also revised to include information about myocarditis and pericarditis following administration of the Janssen COVID‑19 Vaccine. An additional revision to the Fact Sheets was made to include that facial paralysis (including Bell’s Palsy) has been reported during post-authorization use. Also, the scope of authorization (PDF) for a booster dose of the Janssen COVID-19 Vaccine has been revised to reflect that the vaccine may be administered as a first booster dose at least 2 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine. Read more (March 13, 2023)
• FDA posted a revised Moderna COVID-19 Vaccine Presentations Wall Chart (PDF) (March 12, 2023)

FDA permits marketing of first COVID-19 antigen test using traditional premarket review process

FDA granted marketing authorization (PDF) of the Sofia 2 SARS Antigen+ FIA, Sofia SARS Antigen FIA Control Swab Set, intended for prescription use only for the detection of the COVID-19 virus within 6 days of symptom onset and which can be used in a point-of-care setting. The test aids in the diagnosis of COVID-19 for people experiencing symptoms and is to be repeated twice over three days with at least 48 hours between tests. 

Along with this De Novo authorization, the FDA is establishing criteria called special controls that define certain requirements including required labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action also creates a new, Class II regulatory classification for simple devices to directly detect SARS-CoV-2 viral targets from clinical specimens in point-of-care settings or at home use, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.

The granting of this De Novo request for Quidel’s Sofia 2 SARS Antigen+ FIA, Sofia SARS Antigen FIA Control Swab Set, is the latest example of the FDA’s commitment to ensure ongoing access and availability of COVID-19 diagnostic tests. (March 8, 2023)

Where to find lists of cleared and authorized tests

FDA is committed to helping ensure the public has access to a wide variety of test options for COVID-19. Since the start of the pandemic, we have authorized more than 400 antigen and molecular diagnostic tests for SARS-CoV-2. In addition to COVID-19 tests issued EUAs, FDA has cleared several SARS-CoV-2 diagnostic tests through traditional premarket review pathways.

For a list of all molecular SARS-CoV-2 diagnostic tests that have been cleared or granted De Novo classification, see devices with product codes QOF and QQX in FDA’s medical devices databases for 510(k) and De Novo. For a list of all antigen SARS-CoV-2 diagnostic tests that have been cleared or granted De Novo classification, see devices with product code QVF in FDA’s medical devices databases for 510(k) and De Novo.

• 510(k) Premarket Database
• De Novo Premarket Database

EUA revocations

FDA revoked EUAs for these tests for the reasons noted in the revocation letters: 

• March 9, 2023: Idylla Ebola Virus Triage Test (PDF) (Biocartis US, Inc.)
• March 8, 2023: FilmArray NGDS BT‐E Assay (PDF) (BioFire Defense, LLC)

Information about revoked EUAs is available on the web page Emergency Use Authorization--Archived Information. For revoked device EUAs, see: Historical Information about Device Emergency Use Authorizations.

COVID-19 in vitro diagnostic (test) EUAs

As of March 14, 2023, 444 tests and sample collection devices are authorized by FDA under EUAs. These include 299 molecular tests and sample collection devices, 84 antibody and other immune response tests, 60 antigen tests, and 1 diagnostic breath test. There are 78 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 28 EUAs for antigen over-the-counter (OTC) at-home tests, and 5 EUAs for molecular OTC at-home tests. FDA has authorized 45 antigen tests and 8 molecular tests for serial screening programs. FDA has also authorized 1,289 revisions to diagnostic EUA authorizations. Also see: COVID-19 Test Basics  

MCMi FY 2022 Program Update
In February, FDA published the Medical Countermeasures Initiative (MCMi) Program Update report for fiscal year 2022, which showcases FDA's work each year to prepare for all types of public health emergencies. Download a printable PDF. 

COVID-19 at-home tests
Check the List of Authorized At-Home OTC COVID-19 Diagnostic Tests to see if the expiration date for your at-home OTC COVID-19 test has been extended. Bookmark our guide: Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results, and report your positive or negative test results at MakeMyTestCount.org. 

What happens to EUAs when a public health emergency ends?
There are several types of declarations and determinations related to emergencies, including public health emergencies, which serve different purposes. Learn more in this FAQ. Also see, from HHS, Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap. 

Update your antibodies
The virus that causes COVID-19 changes over time. Get your updated COVID-19 vaccine to help protect against COVID’s worst outcomes. Search in your zip code to find a location where a bivalent COVID-19 vaccine booster dose is available near you. 

List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 380 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and use our step-by-step search guide to find out if your product is on the list.