Paul Radensky, MD

McDermott Will & Schulte

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Latest Posts › Medical Devices

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Federal Court Strikes Down LDT Final Rule

On March 31, 2025, the US District Court for the Eastern District of Texas struck down the US Food and Drug Administration’s (FDA) final rule under which FDA would have started regulating most laboratory-developed tests...more

4/4/2025 / Administrative Law Judge (ALJ) , Appeals , Constitutional Challenges , Final Rules , Food and Drug Administration (FDA) , Judicial Review , Medical Devices , Regulatory Authority , Statutory Interpretation

Laboratory-Developed Tests: FDA Publishes Highly Anticipated Proposed Rule

On September 29, 2023, the US Food and Drug Administration (FDA) published a long-awaited proposed rule on laboratory-developed tests (LDTs). If FDA finalizes this rule as proposed, FDA will regulate virtually all LDTs as...more

10/5/2023 / CLIA , Clinical Laboratories , Diagnostic Tests , Food and Drug Administration (FDA) , Laboratory Developed Tests , Legislative Agendas , Life Sciences , Medical Devices , Proposed Regulation , Proposed Rules

CMS Releases Procedural Notice with Comment Period on Transitional Coverage for Emerging Technology

On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a procedural notice with comment period on Transitional Coverage for Emerging Technologies (TCET), a new pathway that uses existing national coverage...more

6/28/2023 / Centers for Medicare & Medicaid Services (CMS) , Emerging Technologies , Food and Drug Administration (FDA) , Medical Devices , Medicare , New Guidance

FDA Outlines Substantially Revised ‘Possible Approach’ to the Regulation of Laboratory-Developed Tests

On January 13, 2017, the US Food and Drug Administration (FDA) posted a “discussion paper” in which the agency outlines a substantially revised “possible approach” to the oversight of laboratory-developed tests (LDTs). The...more

1/26/2017 / Adverse Events , Analytics , Draft Guidance , Food and Drug Administration (FDA) , Laboratory Developed Tests , Medical Devices

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