Support Wanes on FDA Regulating LDTs as Medical Devices Proposed Rule

Three industry groups responding to a Senate committee’s March 14 RFI distributed to stakeholders showed no support for the FDA’s plan to regulate laboratory developed tests.

Acknowledging Congress’ failed efforts to move forward on proposals bringing reform to diagnostics regulation, Sen. Bill Cassidy, (R-La.), ranking member of the Health, Education, Labor and Pensions (HELP) Committee, requested comments from interested parties on more than two dozen questions in the RFI by April 3.

A general sampling of comments received on the RFI — similar to those received last December on related FDA proposed rulemaking — do not reflect overwhelming support for the agency to regulate laboratory developed tests (LDTs) as medical devices under its current structure.

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