Lab Developed Tests News, Articles

Two clinical laboratory scientists wearing PPE in the laboratory hold a clipboard and review the milestones toward the new FDA LDT Final Rule.

Navigating FDA’s LDT Final Rule: Key Terminology Every Clinical Lab Should Know

Shannon Bennett, MS, MBA

As the first milestone of the new LDT Final Rule approaches, here are the key FDA terms laboratories need to understand

Illustration of the words "new rules" in white text against a bright red background net to a large stamp.

Webinar Recap: LDT Compliance Requirements for FDA Final Rule

Christine P. Bump

Christine P. Bump shares key insights from the FDA’s August 22 webinar on LDTs compliance

Photo of the letters F, D, and A, representing the US FDA, on wooden blocks with pills in the background.

Association for Molecular Pathology Challenges FDA in Lawsuit against Final Rule on Laboratory-Developed Test Regulation

Association for Molecular Pathology

Drastic policy change will stifle diagnostic innovation, impose billions of unnecessary dollars in healthcare mandates, and threaten patient access to essential medical procedures

Photo of the word “regulation” in bold capital letters on the side of a file folder.

FDA's Draft Guidances for Emergency Use LDTs Spark Mixed Reactions

Julie Ballard

Public comments to the FDA’s draft guidances proposing enforcement policies for LDTs with and without a 564 Declared Emergency reveal a mix of support and opposition

Photo of a clinical lab professional typing at a laptop keyboard with legal symbols overlayed on top of the photo.

ADLM Supports Letter Asking How the FDA Plans to Abide by SCOTUS Decision Limiting Power of Federal Agencies

Octavia Peck Palmer, PhD

In a statement, ADLM president Octavia Peck Palmer strongly supports Rep. Cassidy’s letter to the FDA asking how the agency plans to change its current practices under the recent Supreme Court ruling

Photo taken of the front of the U.S. Supreme Court showing stairs and large columns.

Future of FDA’s LDT Rule Uncertain with Latest Supreme Court Decision

Scott Wallask, BA

In overturning the Chevron case, justices diminish the power of federal agencies like the FDA

ACLA Sues the FDA Over Final Rule to Regulate Laboratory-Developed Tests as Medical Devices

Scott Wallask, BA

‘FDA’s final rule is the wrong approach’ for LDTs, ACLA president says

Photo of a gavel resting atop of a pile of law books in a US lawmaker’s office.

Trio of Lawmakers Introduces Resolution to Repeal FDA Final Rule on LDTs

Rep. Brad Finstad

Reps. Finstad and Crenshaw, Sen. Paul introduce a resolution under the Congressional Review Act to repeal harmful FDA rule limiting access to laboratory-developed tests