Megan Robertson on Medical Devices

A Final Rule Bites the Dust, Part II: FDA Gives up on Regulating LDTs as Medical Devices

As the song goes, the Food and Drug Administration’s (“FDA’s”) 2024 Final Rule regulating laboratory-developed tests (“LDTs”) as medical devices (“Final Rule”), is not merely dead—it’s really most sincerely dead....more

6/6/2025 / Constitutional Challenges , Food and Drug Administration (FDA) , Judicial Authority , Laboratory Developed Tests , Medical Devices , Regulatory Authority , Regulatory Reform , Rulemaking Process , Statutory Interpretation

The LDT Final Rule Bites the Dust: Examining the Repercussions of the Federal Court’s Vacatur and What the Future May Hold

On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas ruled that the Food and Drug Administration (FDA) lacks the statutory authority to regulate laboratory developed tests...more

4/8/2025 / Administrative Procedure Act , Appeals , Chevron Deference , Food and Drug Administration (FDA) , Judicial Authority , Loper Bright Enterprises v Raimondo , Medical Devices , Regulatory Authority , Statutory Interpretation

A Final Rule Bites the Dust: Federal Court Rules FDA Lacks Authority to Regulate LDTs

The order is in, and the LDT Final Rule is out. In May 2024, the U.S. Food & Drug Administration (“FDA” or the “Agency”) published its Final Rule establishing its regulatory framework over laboratory developed tests...more

4/1/2025 / Final Rules , Food and Drug Administration (FDA) , Judicial Authority , Laboratory Developed Tests , Life Sciences , Medical Devices , Regulatory Authority , Statutory Interpretation

A Regulatory Haze of Uncertainty Continues as the Clock Ticks Toward Phase One of FDA’s LDT Final Rule

Clinical laboratories still face uncertainty and the difficult decision of whether to start the work needed to comply with the with Phase 1 expectations under FDA’s Laboratory Developed Tests Final Rule (the “LDT Final...more

2/27/2025 / Clinical Laboratories , Compliance , Department of Health and Human Services (HHS) , Final Rules , Food and Drug Administration (FDA) , Laboratory Developed Tests , Medical Devices , Regulatory Requirements , Reporting Requirements

Making Moves – FDA’s LDT Proposed Rule Sent to OMB for Review

As of Monday March 4, 2024—just three months after the end of its comment period on December 4, 2023—FDA’s rule on regulation of laboratory developed tests (“LDTs”) as medical devices is under review by the Office of...more

3/8/2024 / Food and Drug Administration (FDA) , Laboratories , Medical Devices , OIRA , OMB

Full Steam Ahead: FDA Releases Proposed LDT Rule in Advance of Looming Government Shutdown

In a last minute push before an anticipated government shutdown, FDA put down its marker for moving forward toward regulation of lab developed tests (“LDTs”). Unlike past proposals from FDA and Capitol Hill, FDA has taken a...more

10/2/2023 / Clinical Laboratory Testing , Food and Drug Administration (FDA) , Government Shutdown , Healthcare , Life Sciences , Medical Devices , Pharmaceutical Industry

FDA’s LDT Proposed Rule Heads to the White House

As discussed in our June Insight, earlier this year FDA publicly announced its development of a proposed rule that would expressly define laboratory developed tests (“LDTs”) as medical devices and subject them to the agency’s...more

8/2/2023 / Clinical Laboratories , Food and Drug Administration (FDA) , Healthcare , Laboratory Developed Tests , Life Sciences , Medical Devices , Pharmaceutical Industry

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

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

6/30/2023 / Biden Administration , Clinical Laboratories , Diagnostic Tests , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Laboratory Developed Tests , Life Sciences , Medical Devices , Notice of Proposed Rulemaking (NOPR) , Regulatory Oversight

FDA Issues Draft Recommendations for Implementing Decentralized Clinical Trials

On May 2, 2023, the U.S. Food and Drug Administration (FDA) took additional steps to support the use of decentralized clinical trials (DCTs) by releasing a new draft guidance titled “Decentralized Clinical Trials for Drugs,...more

6/5/2023 / Clinical Trials , FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Medical Research , Pharmaceutical Industry , Prescription Drugs , Telehealth

The VALID Act: Senate Action Brings FDA Regulation of LDTs Closer to Fruition

Since the passage of the Medical Device Amendments of 1976, FDA has regulated in vitro diagnostic (IVD) tests as medical devices, subject to a full suite of FDA requirements. During that time, FDA has also asserted that it...more

5/23/2022 / Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Medical Devices

Megan Robertson

Epstein Becker & Green

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