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March 2015
POLICY AND ADVOCACY
Laboratory Developed Tests: Regulation Should Keep Pace With ID Patient Needs

IDSA submitted comments to the Food and Drug Administration (FDA) in response to its draft guidance to regulate laboratory developed tests (LDTs), diagnostic devices intended for clinical use that are designed, manufactured, and used within a single laboratory.  IDSA agrees that oversight of LDTs may be appropriate; however, the Society expressed concern that some elements of the regulations could limit patient access to ID testing and provided specific recommendations to address these key issues.  

Diagnostic Task Force member Gregory A. Storch, MD, FIDSA, served on a panel discussion at an FDA public workshop on the regulations, while IDSA staff provided public comments on the regulations. 

IDSA also drafted a response to several questions posed by the House Energy and Commerce Committee about the proposed LDT regulation as well as incentives for diagnostic development.  IDSA stressed the importance of infectious disease diagnostics in patient care, and the need for flexible regulations to allow innovative test development to keep pace with evolving and emerging infectious diseases.



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