What You Should Be Reading: : Guidance, Compliance, & Regulatory Information

FDA Decides Against Issuing Final Guidance on Over Laboratory Developed Tests LDT’s

Sunday, December 17, 2017   (0 Comments)
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Citing stakeholders’ requests for further discussion on appropriate oversight mechanisms and congressional interest in a potential legislative solution to oversight, the FDA has decided against enforcing broad discretionary oversight of LDTs. The agency has published a discussion paper outlining its proposal for phased-in, focused oversight of new and significantly modified high and moderate risk LDTs. 



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