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Regulatory Requirements › Proposed Rules › Clinical Laboratories

McDermott Will & Emery

CMS Implements First Major Updates to Lab Personnel Requirements in 30+ Years

McDermott Will & Emery on

On December 28, 2024, a long-awaited Centers for Medicare & Medicaid Services (CMS) final rule became effective, significantly updating laboratory personnel requirements under Subpart M of the Clinical Laboratory Improvement...more

Bass, Berry & Sims PLC

FDA Takes Definitive Step Toward the Regulation of LDTs

Bass, Berry & Sims PLC on

On October 3, the U.S. Food & Drug Administration (FDA) published a highly anticipated proposed rule (Proposed Rule) to regulate laboratory-developed tests (LDTs) as medical devices. LDTs are tests that are developed and...more

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