PROJECT DESCRIPTION AND TARGET AUDIENCES

Regulation of clinical laboratories has been under the Clinical Laboratory Improvement Amendments (CLIA) since 1988. In 2024, United States (US) Food and Drug Administration (FDA) published a final rule, “Medical Devices; Laboratory Developed Tests” (FDA Docket: FDA-2023-N-2177) hereafter referred to as the “FDA Rule”. If implemented, the FDA Rule will require that all laboratory developed tests (LDTs) and the laboratories developing LDTs comply with medical device regulations.

Recognizing that the FDA Rule represents a fundamental shift in clinical laboratory regulation and practice, the Association for Molecular Pathology (AMP) is conducting a comprehensive survey of subject matter experts from clinical laboratories performing molecular LDTs in CLIA settings to:
  • Understand the impact of the FDA rule on AMP member and non-member clinical laboratory testing and operations;
  • Investigate laboratories' perceptions regarding future directions;
  • Determine what resources are needed to assist laboratories.

Target audiences for this survey: Clinical laboratory directors (includes both doctoral scientists & pathologists) and molecular laboratory professionals performing or directing the use of molecular LDTs in CLIA settings; US and US territory-based clinical laboratories performing molecular LDTs in CLIA settings; not limited to AMP members.

This survey is NOT restricted to AMP members, so please feel free to share the survey link widely with your colleagues who may also be working in this space.
If your organization or company would like to provide feedback on the survey, please contact AMP Clinical Affairs.

T