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FDA To Review Smaller Number Of Emergency Use Requests For COVID-19 Tests

FDA To Review Smaller Number Of Emergency Use Requests For COVID-19 Tests

美国食品药品管理局将审查较少数量的 COVID-19 测试紧急使用申请
Benzinga Real-time News ·  2022/09/27 14:16
  • The FDA said it will now review only a small number of emergency use authorization (EUA) requests for COVID-19 diagnostic tests.
  • The agency encourages developers of all test types interested in marketing authorization to pursue authorization through the de novo classification or 510(k) clearance premarket review pathways.
  • It said companies seeking EUA for their COVID tests would have to apply for the agency's traditional premarket review process.
  • Also Read: No More Free COVID-19 At-Home Tests, Federal Government Says
  • "Taking into account the current status of manufacturing capacity and consumer access...shifting to traditional premarket review would best meet the public health needs at the current stage of the COVID-19 public health emergency," FDA official Jeff Shuren said in a statement.
  • To date, more than 430 different COVID-19 tests have been issued EUAs.
  • FDA intends to focus its review on EUA and supplemental requests for tests that employ new technologies, new variants, or tests funded by a federal agency.
  • The World Health Organization (WHO) also warned that it struggles to identify and track new COVID variants as governments roll back the testing.
  • 美国食品药品监督管理局表示，现在将只审查一小部分新冠肺炎诊断测试的紧急使用授权请求。
  • 该机构鼓励对营销授权感兴趣的所有测试类型的开发商通过从头分类或510(K)许可上市前审查途径寻求授权。
  • 它说，为COVID测试寻求EUA的公司将必须申请该机构传统的上市前审查程序。
  • 也请阅读：联邦政府表示，不再有免费的新冠肺炎上门测试
  • 食品药品监督管理局官员Jeff在一份声明中表示：“考虑到当前的产能和消费者准入状况……转向传统的售前审查将最好地满足现阶段新冠肺炎突发公共卫生事件的公共卫生需求。”
  • 到目前为止，已经签发了430多种不同的新冠肺炎检测欧盟协议。
  • FDA打算将审查重点放在EUA和使用新技术、新变种或由联邦机构资助的测试的补充请求上。
  • 世界卫生组织(WHO)也警告说，随着各国政府取消检测，它难以识别和跟踪新的COVID变种。
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