- For Immediate Release:
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- Today, the FDA issued a proposed rule to amend the color additive regulations to increase the fees for certification services.
- Today, the FDA revised the emergency use authorizations (EUAs) of all COVID-19 antigen tests to revise the authorized uses and require updates to product labeling regarding repeat or serial testing. The letter issued today also eliminates one Condition of Authorization that is no longer needed. Today’s action is in response to available data about the performance of COVID-19 antigen tests showing that repeat testing after a negative COVID-19 antigen test result increases the chance of an accurate result, in people with and without symptoms, and could help prevent people from unknowingly spreading the SARS-CoV-2 virus to others.
- The FDA communicated recommendations consistent with this revision in the August 11, 2022, Safety Communication: At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative.
- The EUA revision requires test developers in the scope of the revision to update product labeling to include the revised authorized uses:
- Repeat testing at least 2 times over 3 days with at least 48 hours between tests for people with COVID-19 symptoms.
- Repeat testing at least 3 times over 5 days with at least 48 hours between tests for people without COVID-19 symptoms.
- On Monday, the FDA issued a safety communication to alert patients, caregivers, and health care providers about a shortage of tracheostomy tubes, including Bivona tracheostomy tubes manufactured by ICU Medical. A shortage of Bivona tracheostomy tubes is more likely to impact pediatric patients because the supply of alternative tubes with similar functionality may be limited. The FDA is working closely with manufacturers and other stakeholders to quickly help resolve supply challenges and support availability of these critical devices for patients who need them. People who use these tubes, including caregivers and health care providers, should consider the FDA’s recommendations listed in the safety communication.
- On Friday, the FDA updated the answer to the questions, “I am developing a COVID-19 diagnostic test? How can I obtain appropriate test materials for assay validation?” on the COVID-19 Test Development and Review FAQs. See the revised answer: COVID-19 Test Development and Review: FAQs on Testing for SARS-CoV-2.
- Each month, the FDA Grand Rounds lecture series highlights a key public health challenge, and how the FDA is applying science and innovation to its regulatory activities. The agency invites you to attend the next presentation on Nov. 17, 2022, from 12 to 1 p.m. ET, on the topic, “Medical Extended Reality: Applications and Challenges.” The lecture will include an overview of augmented and virtual reality technology and of the landscape of potential medical applications, in addition to regulatory science efforts to address evaluation challenges for using augmented and virtual reality in medicine.
- COVID-19 testing updates:
- As of today, 435 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 298 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 77 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, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 4 for molecular OTC at-home tests.
- The FDA has authorized 35 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1145 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