Laboratory-Developed Testing Procedures

AMP's work on LDTs

Laboratory-developed testing procedures are services that hospitals and academic and clinical laboratories develop and use in patient care. These services are not commercially manufactured and marketed but are designed, developed, validated, performed and interpreted by board-certified professionals in a single laboratory.

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AMP v. FDA lawsuit 

AMP will be using this page to communicate with our community on the impact of the U.S. Food and Drug Administration's final rule on LDTs.

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FDA rule resources for laboratories

AMP maintains a list of resources as a service to our membership and the molecular laboratory community.

See the resources