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FDA Issues Proposed Rule on Laboratory Developed Tests

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The Food and Drug Administration (FDA) has published a proposed rule on the regulation of laboratory developed tests (LDTs). Comments on the proposed rule are due Dec. 4.  

Specifically, the proposed rule would make explicit that in vitro diagnostic (IVD) products are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer is a laboratory.  

When the proposed policy is fully phased in over four years, the agency would require all IVD makers to meet the applicable regulatory requirements for medical devices, except where meeting certain requirements under the Clinical Laboratory Improvement Amendments can be leveraged. The FDA also seeks comments on alternative enforcement approaches for some IVDs offered as LDTs, including a different approach for academic medical center laboratories, the continuation of the current general enforcement discretion approach with respect to premarket review and quality system requirements for some or all currently marketed LDTs, and a phase-out period tailored for small laboratories.