AMP v. FDA Lawsuit

AMP will be using this page to communicate with our community on the impact of the U.S. Food and Drug Administration's (FDA) Final Rule on Medical Devices: Laboratory Developed Tests (LDTs).

Association for Molecular Pathology Wins Lawsuit Against FDA Challenging Final Rule on Regulation for Laboratory Developed Testing Procedures

Read the Ruling in AMP's Favor (3/31/2025)

Read the Opinion in AMP's Favor (3/31/2025)

Read the AMP Complaint (8/19/2024)

Read the Press Release

Declaration of Karen Kaul, MD, PhD

Declaration of Eric Konnick, MD, MS

Read AMP's Opening Brief (9/27/2024)

Read the Department of Justice's (DOJ) Brief (10/25/2024)

Read AMP's Closing Brief (11/25/2024)

Read the Department of Justice's (DOJ) Closing Brief (12/23/2024)

Events

A Discussion on the Recent AMP Lawsuit Filing

September 16, 2024

Please view the presentation slides here.

AMP Webinar on the Final Rule: FDA Rule Medical Device; Laboratory Developed Tests
May 9, 2024

This webinar updated the community on the intricacies of the final rule and the next steps laboratories need to take.

You can find a recording of the webinar here.

Please view the presentation slides here.

Learn About AMP's Position on Regulation of Laboratory Developed Testing Procedures (LDPs)

Resources:

FDA Final Rule on Medical Devices: Laboratory Developed Tests

Watch the FDA webinar on how to comply with medical device reporting (MDR) requirements, correction and removal reporting requirements, and quality system (QS) requirements regarding complaint files beginning May 6, 2025 below.