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 

In March 2025, AMP won its lawsuit against the FDA over the agency's final rule on the regulation of LDTs. See our court filings and the judge's decision, which the U.S. government declined to appeal.

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FDA rule resources for laboratories

In response to the FDA's final rule, AMP created a list of resources for our members and others in the molecular laboratory community. The March 2025 court ruling in AMP's favor vacated the rule.

See the resources