- For Immediate Release:
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- On April 7, the FDA authorized an extension for the shelf life of the refrigerated Janssen COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees Celsius for 11 months. The vaccine was previously authorized to be stored for up to nine months. This extension was granted following a thorough review of data submitted by Janssen. This extension applies to all refrigerated vials of Janssen COVID-19 Vaccine that have been held in accordance with the manufacturer’s storage conditions. A copy of the concurrence letter is posted on FDA’s website.
- On April 7, the FDA authorized two over-the-counter (OTC) at-home COVID-19 antigen tests. The validation data was gathered through the FDA’s collaboration with the National Institutes of Health (NIH) and the Independent Test Assessment Program (ITAP). The emergency use authorizations (EUA) issued to Osang LLC was for their OHC COVID-19 Antigen Self-Test and Xiamen Boson Biotech Co., Ltd for their Rapid SARS-CoV-2 Antigen Test Card. These are examples of the FDA’s ongoing commitment to increase the availability of appropriately accurate and reliable at-home COVID-19 diagnostic tests for all Americans.
The tests are:
- OTC at-home COVID-19 antigen diagnostic tests that show results in 15 minutes.
- Intended for use as a serial test for people with or without symptoms, meaning the test is done two times over three days, with at least 24 hours and no more than 48 hours between tests.
Can be used for people:
- • Age 14 years or older with a self-collected nasal swab sample.
- • Age 2 years or older when an adult collects the nasal swab sample.
- On April 7, the FDA issued the draft guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. The draft guidance replaces the 2018 draft guidance and is intended to further emphasize the importance of ensuring that devices are designed securely, enabling emerging cybersecurity risks to be mitigated throughout the Total Product Life Cycle, and to outline the FDA’s recommendations more clearly for premarket submission content to address cybersecurity concerns.
- As part of the FDA’s effort to protect consumers, on April 6, the agency issued a warning letter jointly with the Federal Trade Commission to Sensory Cloud, Inc for selling unapproved products with unproven COVID-19 claims. Consumers concerned about COVID-19 should consult with their health care provider.
- COVID-19 testing updates:
- As of today, 428 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 294 molecular tests and sample collection devices, 84 antibody and other immune response tests and 50 antigen tests. There are 74 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, 17 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
- The FDA has authorized 28 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 923 revisions to EUA authorizations.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- FDA Office of Media Affairs