James Boiani 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

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

Unpacking Averages: Analyzing the Relationship Between MDRs and Recalls

Recently Colleen and Brad had a debate about whether Medical Device Reports (“MDRs”) tend to trail recalls, or whether MDRs tend to lead to recalls. Both Colleen and Brad have decades of experience in FDA regulation, but we...more

8/2/2023 / Food and Drug Administration (FDA) , Healthcare , Life Sciences , Medical Device Reports (MDRs) , Medical Devices , Pharmaceutical Industry , Product Recalls

TAKE TWO: CMS’s Second Attempt to Streamline Breakthrough Device Coverage Limited to 5 Devices Per Year

On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) announced its proposed “Transitional Coverage for Technologies” (TCET) pathway—the Biden administration’s highly anticipated take on a mechanism to expedite...more

7/21/2023 / Centers for Medicare & Medicaid Services (CMS) , Health Insurance , Healthcare , 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

Congress Clarifies the Regulatory Classification of Contrast Agents, Radioactive Drugs, and OTC Monograph Drugs

On December 29, 2022, President Biden signed into law H.R. 2617, the Consolidated Appropriations Act of 2023 (CAA23). Buried in this massive piece of legislation is Section 3621, Regulation of Certain Products as Drugs, which...more

1/20/2023 / Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Medical Devices , Over The Counter Drugs (OTC) , Pharmaceutical Industry , Prescription Drugs

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

FDA Takes a Bold Step Toward Laboratory Developed Test Regulation: How Labs and IVD Manufacturers Should Prepare for the Future

On July 31, 2014, the U.S. Food and Drug Administration ("FDA") announced plans to regulate laboratory developed tests ("LDTs"). In this Client Alert, we explore FDA's proposed regulatory framework for LDTs and discuss some...more

9/9/2014 / Clinical Laboratories , Food and Drug Administration (FDA) , Laboratory Developed Tests , Manufacturers , Medical Devices , Regulatory Standards

James Boiani

Epstein Becker & Green

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