Chair Rodgers Statement on FDA's Lab Developed Test Rule

Statement

This rule goes well beyond any of the proposed LDT legislation and will stifle innovation of diagnostics, such as those used to detect rare diseases. By adding new costly regulations, patients could lose access to diagnostics that identify potentially fatal conditions. Any LDT policy should go through the legislative process with deliberative consideration by the committees of jurisdiction. In order to strike the appropriate balance between adequate protections of public health and facilitating innovation, the FDA should rescind this rule and allow Congress--the people's voice--to consider the matter.

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