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, […]
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
- By Joseph Burns
- > From the Volume XXI No.16 - November 24, 2014 Issue
