Laboratory Developed Testing Procedures (LDPs)

NEW: The Verified Innovative Testing in American Laboratories (VITAL) Act of 2020

AMP is proud to announce that Senator Rand Paul introduced the Verified Innovative Testing in American Laboratories (VITAL) Act of 2020! The VITAL Act's main provisions work to clarify that the regulation of LDPs rests within the CLIA program under CMS and not the FDA, including during a public health emergency, and defines LDPs as a professional medical service, a position that AMP has supported for many years. The VITAL Act is a great first step in the right direction to establish a more efficient regulatory framework that ensures high-quality patient care while continuing to foster the rapid innovation and promise of new diagnostic technologies.

Related links:
AMP's Press Release
Introduced Legislative Text

To ask your Representatives and Senator to co-sponsor the bill and to learn more about the VITAL Act of 2020, please visit:


AMP's CLIA Modernization Proposal of 2015


AMP's Principles for Oversight of LDPs

AMP Position Statement: Revisiting Oversight and Regulation of Molecular-Based Laboratory-Developed Tests


AMP Activity:

Verifying Accurate Leading-edge IVCT Development (VALID) Act Draft Legislation:

Diagnostic Accuracy and Innovation Act (DAIA) Draft Legislation:

FDA Draft Guidance on Oversight of LDPs



Additional Resources Relating to Regulation of Laboratory Developed Testing Procedures

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