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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

美國食品藥品管理局將審查較少數量的 COVID-19 測試緊急使用申請
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.
  • 美國食品藥品監督管理局表示，現在將只審查一小部分新冠肺炎診斷測試的緊急使用授權請求。
  • 該機構鼓勵對營銷授權感興趣的所有測試類型的開發商通過從頭分類或510(K)許可上市前審查途徑尋求授權。
  • 它說，為COVID測試尋求EUA的公司將必須申請該機構傳統的上市前審查程式。
  • 也請閱讀：聯邦政府表示，不再有免費的新冠肺炎上門測試
  • 食品藥品監督管理局官員Jeff在一份聲明中表示：“考慮到當前的產能和消費者準入狀況……轉向傳統的售前審查將最好地滿足現階段新冠肺炎突發公共衛生事件的公共衛生需求。”
  • 到目前為止，已經簽發了430多種不同的新冠肺炎檢測歐盟協定。
  • FDA打算將審查重點放在EUA和使用新技術、新變種或由聯盟機構資助的測試的補充請求上。
  • 世界衛生組織(WHO)也警告說，隨著各國政府取消檢測，它難以識別和跟蹤新的COVID變種。
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