Attorneys Outline Issues in FDA’s LDT Guidance

CEO SUMMARY: Officials at the FDA believe that CLIA does not go far enough because it does not address the issues of whether laboratory-developed tests (LDTs) have been designed correctly or have been manufactured in accordance with sound standards. Also, CLIA does not include a process to verify if LDTs are safe, accurate, or efficacious, …

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Attorneys Outline Issues in FDA’s LDT Guidance

Labs have opportunity to provide comments; FDA wants to be notified of all LDTs a lab performs

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