Regulatory Oversight, Medical Devices, Clinical Laboratories

Federal Court Blocks FDA’s Final Rule on LDTs: Key Considerations for Clinical Labs

Morgan Lewis on 4/22/2025

The US District Court for the Eastern District of Texas issued a pivotal ruling in the consolidated lawsuit American Clinical Laboratory Association v. US Food and Drug Administration (FDA) challenging FDA’s final rule to end...more

District Court Vacates FDA LDT Rule; What’s Next for Regulation of Lab Testing?

Akin Gump Strauss Hauer & Feld LLP on 4/4/2025

On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA. Judge Jordan’s decision vacates and sets...more

FDA’s Proposed Rule for Oversight of Laboratory Developed Tests: Part I: Underpinnings of FDA’s Proposed Rule

Goodwin on 10/9/2023

On October 3, 2023, the U.S. Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). The proposed rule and policy are the latest in an over...more

What’s on the Agenda? Laboratory Developed Tests Added to the Unified Regulatory Agenda Signals FDA Movement Toward New Regulatory...

Epstein Becker & Green on 6/30/2023

The Food and Drug Administration (“FDA” or “agency”) intends to issue a notice of proposed rulemaking in August 2023 that will “make explicit” that laboratory developed tests (LDTs) are devices under the federal Food, Drug,...more

Regulatory Oversight › Medical Devices › Clinical Laboratories

Federal Court Blocks FDA’s Final Rule on LDTs: Key Considerations for Clinical Labs

District Court Vacates FDA LDT Rule; What’s Next for Regulation of Lab Testing?

FDA’s Proposed Rule for Oversight of Laboratory Developed Tests: Part I: Underpinnings of FDA’s Proposed Rule

What’s on the Agenda? Laboratory Developed Tests Added to the Unified Regulatory Agenda Signals FDA Movement Toward New Regulatory...

FDA Oversight of Laboratory-Developed Tests Continues To Evolve

Evolution & Revolution: Device Policy Priorities at FDA in 2019

FDA Issues a Second Draft Guidance on Clinical Decision Support Software

Regulatory Oversight › Medical Devices › Clinical Laboratories

Federal Court Blocks FDA’s Final Rule on LDTs: Key Considerations for Clinical Labs

District Court Vacates FDA LDT Rule; What’s Next for Regulation of Lab Testing?

FDA’s Proposed Rule for Oversight of Laboratory Developed Tests: Part I: Underpinnings of FDA’s Proposed Rule

What’s on the Agenda? Laboratory Developed Tests Added to the Unified Regulatory Agenda Signals FDA Movement Toward New Regulatory...

FDA Oversight of Laboratory-Developed Tests Continues To Evolve

Evolution & Revolution: Device Policy Priorities at FDA in 2019

FDA Issues a Second Draft Guidance on Clinical Decision Support Software

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