Pathologists Take Alternative Lab Test Regulation Proposal to Senate | GenomeWeb

NEW YORK (GenomeWeb) – The Association for Molecular Pathology has come up with its own plan (see PDF below) for regulating laboratory test procedures as an alternative to the US Food and Drug Administration's draft guidance.

The proposal seeks to maintain oversight of lab-developed test procedures (LDPs) largely under the traditional pathway via the Centers for Medicare & Medicaid Services' Clinical Laboratory Improvement Amendments (CLIA), but with changes that expand the agency's regulatory muscle.

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