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FDA Roundup: June 14, 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:

  • On Monday, the FDA’s Center for Devices and Radiological Health (CDRH) announced plans to study how patients weigh the benefits and risks associated with smooth and textured breast implants. Including the risk of Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), which appears more often in patients with textured breast implants. CDRH expects the survey results will help assess whether patients’ perception of risks of BIA-ALCL associated with textured breast implants, are influenced by information about potential benefits of textured breast implants. The insights gained through this patient-centered approach will help incorporate patient preferences in CDRH’s regulatory decision-making. The Center plans to publish the results of this study later this year, CDRH has contracted with Research Triangle Institute International to conduct this study. 
  • On Friday, the FDA issued an emergency use authorization (EUA) for the Laboratory Corporation of America (Labcorp) VirSeq SARS-CoV-2 NGS Test on the PacBio Sequel II sequencing system. The SARS-CoV-2 virus has mutated over time resulting in genetic variation in circulating virus strains, also called lineages. The Labcorp VirSeq SARS-CoV-2 NGS Test is: 
    • The first COVID-19 test authorized for the identification and differentiation of SARS-CoV-2 Phylogenetic Assignment of Named Global Outbreak (PANGO) lineages.
    • A next-generation sequencing (NGS) based test authorized for testing patient respiratory samples (such as anterior nasal or nasopharyngeal swab samples) identified as SARS-CoV-2 positive using Labcorp’s COVID-19 RT-PCR Test and Labcorp SARS-CoV-2 & Influenza A/B Assay. 
    • Intended to be used when a health care provider decides, based on a patient’s medical history and other diagnostic information, that the test results may help in deciding the appropriate clinical care for the patient.
    • The test can be performed at certain laboratories designated by Labcorp that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) that meet the requirements to perform high-complexity testing.
  • COVID-19 testing updates:
    • As of today, 437 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, 49 antigen tests, and 1 diagnostic breath test. There are 80 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 27 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1003 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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