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).
NEWS! Association for Molecular Pathology Files Lawsuit Against FDA to Challenge Final Rule on Regulation for Laboratory Developed Testing Procedures
Read the AMP Complaint (8/19/2024)
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)
A Discussion on the Recent AMP Lawsuit Filing
September 16, 2024 - 4-5pm Eastern
Please view the presentation slides here.
AMP Webinar on the Final Rule: FDA Rule Medical Device; Laboratory Developed Tests
May 9, 2024 – 1:00 PM Eastern
To update the community on the intricacies of the final rule and the next steps laboratories need to take, AMP held a webinar on May 9, 2024, at 1:00 PM Eastern Time.
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)
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.
Click here for upcoming FDA events
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