AMP v. FDA Lawsuit 

AMP win against FDA will stand

U.S. government forgoes appeal in LDTs case

June 3, 2025 | The U.S. Food and Drug Administration has officially declined to appeal the recent court ruling in AMP v. FDA. This decision leaves in place the decision that the FDA does not have the authority to impose premarket review requirements on laboratory-developed testing procedures without clear legislative direction.

This outcome represents a major victory for AMP and our members. It reinforces the critical role of clinical laboratories in developing and delivering innovative, high-quality diagnostics and recognizes the unique regulatory framework under which these tests have safely operated for decades.

We remain committed to advocating for a science-based, patient-centered approach to oversight of molecular diagnostic testing. As we look ahead, we will continue working with Congress, federal agencies and stakeholders to advance policies that support innovation, safeguard patient care and respect the vital contributions of our professional community.

Thank you for your continued engagement and support.

Learn about AMP's position on regulation of laboratory-developed testing procedures.

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.