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Home › Business, Policy & Funding › Regulatory News & FDA Approvals › FDA Decision to Halt EUA Review of LDTs Raises Reimbursement, Liability Questions for Labs

FDA Decision to Halt EUA Review of LDTs Raises Reimbursement, Liability Questions for Labs

Oct 12, 2020
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Adam Bonislawski
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NEW YORK – The US Food and Drug Administration's announcement last week that it will no longer review SARS-CoV-2 Emergency Use Authorization submissions for laboratory-developed tests has created new uncertainty for laboratories amidst an already tumultuous environment.

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