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FDA Summary: April 8, 2022

For immediate release:

Today, the U.S. Food and Drug Administration provides an at-a-glance summary of news from the agency:

  • On April 7, the FDA authorized a shelf-life extension for Janssen COVID-19 refrigerated vaccine, allowing the product to be stored at 2-8 degrees Celsius for 11 months. The vaccine was previously allowed to be stored for up to nine months. This extension was granted following a thorough review of the data submitted by Janssen. This extension applies to all refrigerated vials of Janssen COVID-19 Vaccine that have been stored in accordance with the manufacturer’s storage conditions. A copy of the approval letter is posted on the FDA website.
  • On April 7, the FDA authorized two over-the-counter (OTC) home COVID-19 antigen tests. Validation data was collected through the FDA’s collaboration with the National Institutes of Health (NIH) and the Independent Test Assessment Program (ITAP). The Emergency Use Authorizations (EUAs) issued to Osang LLC were for their OHC COVID-19 antigen self-test and Xiamen Boson Biotech Co., Ltd for their SARS-CoV-2 antigen rapid test card. These are examples of the FDA’s continued commitment to increasing the availability of sufficiently accurate and reliable home COVID-19 diagnostic tests for all Americans.
    The tests are:
    • Over-the-counter COVID-19 home antigen diagnostic tests that give results in 15 minutes.
    • Intended to be used as a serial test for people with or without symptoms, meaning the test is carried out twice over three days, with at least 24 hours and no more than 48 hours between tests.

    Can be used for people:

    • • Be 14 years of age or older with a self-collected nasal swab specimen.
    • • Age 2 years or older when an adult collects the nasal swab specimen.
  • On April 7, the FDA released the draft guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. The draft guidance replaces the draft guidance from 2018 and aims to further emphasize the importance of ensuring that devices are designed in a secure manner, helping to mitigate emerging cybersecurity risks throughout the total product lifecycle, and to more clearly describe FDA recommendations for premarket submission content. to address cybersecurity concerns.
  • As part of the FDA’s efforts to protect consumers, on April 6, the agency issued a joint warning letter with the Federal Trade Commission to Sensory Cloud, Inc for selling unapproved products with COVID-19 claims. 19 unproven. Consumers concerned about COVID-19 should consult their healthcare provider.
  • COVID-19 testing updates:
    • To date, 428 tests and specimen collection devices are authorized by the FDA under Emergency Use Authorizations (EUAs). These include 294 molecular tests and sample collection devices, 84 antibody tests and other immune response tests and 50 antigen tests. There are 74 molecular clearances and 1 antibody clearance that can be used with home samples. There is 1 EUA for molecular prescription home testing, 2 EUA for antigen prescription home testing, 17 EUA for over-the-counter (OTC) antigen home testing and 3 for home testing Molecular OTCs.
    • The FDA has authorized 28 antigen tests and 9 molecular tests for serial screening programs. The FDA also cleared 923 revisions to EUA clearances.

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The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.