FDA Roundup: May 09, 2023

FDA News Release

• For Immediate Release: May 09, 2023

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

• On Friday, the FDA granted marketing authorization of the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack for use with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack for use with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total for use with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator, both manufactured by Ortho-Clinical Diagnostics, Inc. These tests are intended for prescription use only for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma samples collected on or after 15 days post-symptom onset as an aid in identifying individuals who have an adaptive immune response to SARS-CoV-2 from either a recent or prior infection. Serology tests detect the presence of antibodies to SARS-CoV-2 and do not detect the virus itself. This is one reason that serology tests should not be used to diagnose or exclude acute COVID-19 infection. The sensitivity of the tests in early infection is unknown. Negative results do not mean that the tested individual is free from an acute SARS-CoV-2 infection. If acute infection is suspected, diagnostic testing, such as a PCR or antigen test for COVID-19, is necessary. 
• These are the first marketing authorizations for serology COVID-19 tests using a traditional premarket review process. The granting of these De Novo requests for Ortho-Clinical Diagnostics, Inc., is the latest example of the FDA’s ongoing commitment to maintain access to tests related to COVID-19.   
• On Wednesday, the FDA published a new web page with details about over-the-counter (OTC) Hearing Aids: What You Should Know before and after buying an OTC hearing aid.
• COVID-19 testing updates: 
  • As of today, 449 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 302 molecular tests and sample collection devices, 83 antibody and other immune response tests, 63 antigen tests, and one diagnostic breath test. There are 78 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, two EUAs for antigen prescription at-home tests, 30 EUAs for antigen over-the-counter (OTC) at-home tests, and four for molecular OTC at-home tests.
  • The FDA has authorized 48 antigen tests and seven molecular tests for serial screening programs. The FDA has also authorized 1362 revisions to EUA authorizations.