FDA permits marketing of first COVID-19 at-home test using traditional premarket review process | Join us for the FDA Science Forum June 13-14

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

• June 6, 2023: FDA Roundup including a Letter to Health Care Providers recommending health care facilities and health care providers implement conservation strategies for non-sterile, single-use pneumatic tourniquet cuffs in the United States
• June 6, 2023: FDA Permits Marketing of First COVID-19 At-Home Test Using Traditional Premarket Review Process
• June 6, 2023: FDA Announces Additional Steps to Modernize Clinical Trials
• June 2, 2023: FDA Roundup including approval of the second respiratory syncytial virus (RSV) vaccine approved for use in the United States
• May 31, 2023: FDA approved a second vaccine for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in individuals 60 years and older
• May 31, 2023: Hurricane Emergency Preparedness and Medical Devices: Recommendations for Health Care Providers, Device Manufacturers and Distributors (new web page)
• May 31, 2023: The FDA Center for Drug Evaluation and Research (CDER) Office of Surveillance and Epidemiology published its 2022 Annual Report (PDF), including continued response to public health emergencies
• May 31, 2023: Update on In-Person Face-to-Face Formal Meetings with FDA (updated)

FDA granted marketing authorization for the Cue COVID-19 Molecular Test. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in nasal swabs from adults with signs and symptoms of upper respiratory infection. This test is the first at-home over-the-counter (OTC) test for COVID-19 to be granted marketing authorization using a traditional premarket review pathway and the first ever at-home test authorized using a traditional premarket review pathway for any respiratory illness. (June 6, 2023)

Resources to help you plan for potential emergencies

The 2023 Atlantic hurricane season began on June 1, 2023, and ends on November 30, 2023. While FDA and other agencies work hard every day to help prepare the nation for potential threats, everyone can be involved in disaster readiness. Learn what you can do now to prepare.

EUA revocations

FDA revoked the following EUAs for the reasons noted in the revocation letters (PDFs) and below: 

• June 1, 2023: Janssen COVID-19 Vaccine (Janssen Biotech, Inc.) - On May 22, 2023, Janssen Biotech, Inc. requested the voluntary withdrawal of the EUA of the Janssen COVID-19 Vaccine. Janssen Biotech, Inc. informed the FDA that the last lots of the vaccine purchased by the U.S. Government have expired, there is no demand for new lots of the vaccine in the U.S., and they do not intend to update the strain composition of this vaccine to address emerging variants. On June 1, 2023, FDA revoked the EUA for this vaccine.  
• June 1, 2023: Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test and Biosearch Technologies SARS-CoV-2 ultra-high-throughput End-Point RT-PCR Test (LGC, Biosearch Technologies)

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.

EUA quick links

• Emergency Use Authorization - about EUAs, and links to current EUAs
• EUAs for Drugs and Non-Vaccine Biological Products (CDER)
• EUAs for Medical Devices (CDRH)
• COVID-19 Vaccines, including vaccine-specific pages with EUA info (CBER)
• Emergency Use Authorization--Archived Information - EUAs that are no longer in effect because they have been terminated or revoked
• Historical Information about Device EUAs

Quick COVID-19 resources

• Check expiration date extensions for your COVID-19 tests 
• Get the latest on COVID-19 vaccines
• Know your treatment options for COVID-19

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: End of the COVID-19 Public Health Emergency

List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 450 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and learn more about safely using hand sanitizer.