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FDA Roundup: August 16, 2022

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 final rule to improve access to hearing aids which may in turn lower costs for millions of Americans. This action establishes a new category of over-the-counter (OTC) hearing aids, enabling consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or a fitting adjustment by an audiologist.
  • Monday, the FDA warned the public about certain spray sunscreens that have been recalled because of benzene contamination in a Consumer Update. Sun safety is always in season. It’s important to protect your skin from sun damage throughout the year, no matter the weather. The FDA continues to evaluate sunscreen products to ensure that they are safe and effective.
  • Monday, the FDA launched a new external webpage to highlight the Operation Lascar Initiative. Operation Lascar, with the United Kingdom (U.K.), is the FDA’s first bilateral initiative focused on the movement of illicit FDA-regulated products. It started in 2017, recognizing that any effective attempt at halting the illicit shipment of FDA-regulated products to the United States from and through the U.K. would require marshalling the forces of multiple U.S. and U.K. agencies. The site provides a history of the Initiative, key milestones, and a look ahead at the upcoming two-day symposium in September.  This symposium will bring together leaders from industry, government, and the international community to explore regulatory and legal weaknesses and identify multinational and whole-of-governments solutions.
  • Friday, the FDA cleared the Visibly Digital Acuity Product, a web-based, self-guided software application intended for use by adults ages 22 to 40 who have the capability to perform a self-test at home, to aid in the evaluation of visual acuity with or without correction. The application’s recommendations are intended to be supportive recommendations that will be used by an eye care provider, along with the patient’s medical history and profile, prior corrective eyewear prescriptions, and subjective vision data. This device does not provide screening or diagnosis of eye health or other disease and does not replace an eye health exam with a licensed provider.
  • COVID-19 testing updates:  
    • As of today, 439 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 302 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 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, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
    • The FDA has authorized 31 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1084 revisions to EUA authorizations
       

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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.


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