COVID-19 and mpox testing updates | Data standards for Animal Rule studies

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

• March 21, 2023: FDA Roundup including a warning letter to a website for offering drugs for sale in the U.S. that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19
• March 17, 2023: FDA Roundup including an EUA for the Cue Mpox (Monkeypox) Molecular Test (PDF) for use in a point-of-care setting
• March 17, 2023: Center for Drug Evaluation and Research (CDER) Office of Compliance 2022 Annual Report (PDF), including a spotlight on the office's activities to support public health emergency response
• March 16, 2023: Medical Device Shortages During the COVID-19 Public Health Emergency (updated)
• March 15, 2023: Final Guidance: Definitions of Suspect Product and Illegitimate Product for Verification Obligations, as part of the agency’s implementation of the Drug Supply Chain Security Act (DSCSA)
• March 14, 2023: What can I do to protect myself from getting COVID-19 again? (new video)

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

Join the last recurring virtual town hall today

Based on current COVID-19 trends, FDA decided that March 22, 2023, will be the last virtual town hall on test development and validation during the mpox and COVID-19 public health emergencies. Over the last three years, the FDA hosted more than 100 virtual town halls on test development and validation to provide information and answer questions about COVID-19 and mpox tests. If you continue to have questions about test development and validation, please email COVID19Dx@fda.hhs.gov or MPXDx@fda.hhs.gov. FDA may schedule ad hoc webinars on special topics in the future.

New mpox point-of-care test

FDA issued an EUA (PDF) for the Cue Mpox (Monkeypox) Molecular Test for use in a point-of-care (POC) setting. The Cue Mpox (Monkeypox) Molecular Test is molecular-based test intended to detect monkeypox virus DNA in lesion swab specimens from individuals suspected of mpox by their health care provider. This EUA is the latest example of FDA’s ongoing commitment to advance greater consumer access to tests for infectious diseases. Learn more: Monkeypox (mpox) Emergency Use Authorizations for Medical Devices (March 17, 2023)

Reminder: Where to find lists of cleared and authorized COVID-19 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

FDA worked with the Clinical Data Interchange Standards Consortium (CDISC) to develop electronic data standards for the natural history and efficacy studies conducted in animals that support Animal Rule applications. The Standard for Exchange of Nonclinical Data (SEND) Implementation Guide-Animal Rule v1.0 (SENDIG-AR v1.0) was published by CDISC on September 17, 2019, and FDA’s support for these data standards began on March 15, 2020.

SEND data sets are required in Animal Rule submissions to the Center for Drug Evaluation and Research (CDER) for studies initiated after March 15, 2022, for new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) and for studies initiated after March 15, 2023, for certain investigational new drug applications (INDs).

To learn more about the requirements for data standards for Animal Rule submissions to CDER, see FDA’s Animal Rule Information web page.

Amended EUA determination (COVID-19)

On March 17, 2023, HHS issued a notice that, effective March 15, 2023, the HHS Secretary amended the February 4, 2020 determination made pursuant to section 564 of the FD&C Act and determined pursuant to his authority under section 564(b)(1)(C) that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad and that involves a biological agent, namely the novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (SARS-CoV-2).

The four previously-issued section 564 declarations that refer to the February 4, 2020 determination have not been terminated by the Secretary because, among other things, the circumstances described in section 564(b)(1) continue to exist—i.e., COVID-19, a disease attributable to SARS-CoV-2, continues to present a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad. Consistent with section 564(f), the currently-in-effect EUAs issued under those section 564 declarations remain in effect until the earlier of the termination of relevant section 564 declarations under section 564(b), or revocation of the EUAs. Therefore, these EUAs, including for tests, other devices, treatments, and vaccines, continue to remain in effect. Also see: FAQs: What happens to EUAs when a public health emergency ends?

COVID-19 in vitro diagnostic (test) EUAs

As of March 21, 2023, 445 tests and sample collection devices are authorized by FDA under EUAs. These include 300 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 1,305 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.