News & Analysis as of

Proposed Rules CLIA Department of Health and Human Services (HHS)

McDermott Will & Emery

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

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

Mintz - Health Care Viewpoints

Five Topline Takeaways from FDA’s Proposed Rulemaking on Lab-Developed Tests

It came as a surprise to nobody in health care circles when, on Friday, September 29, 2023, the Food and Drug Administration (FDA) publicly announced that its much-anticipated proposed rule on laboratory developed tests, or...more

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