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: www.amp.org/TakeAction.

AMP's CLIA Modernization Proposal of 2015

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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:

• Comments on the Verifying Accurate Leading-edge IVCT Development (VALID) Act Draft Legislation

Diagnostic Accuracy and Innovation Act (DAIA) Draft Legislation:

• Comments on FDA's Technical Assessment of the Diagnostic Accuracy and Innovation Act Draft Legislation
• Supplemental Comments to Reps. Bucshon and DeGette on Diagnostic Accuracy and Innovation Act Draft Legislation
• Comments to Reps. Bucshon and DeGette on Diagnostic Accuracy and Innovation Act Draft Legislation

FDA Draft Guidance on Oversight of LDPs

• Written comments to FDA on Proposed Oversight of LDPs

Additional Resources Relating to Regulation of Laboratory Developed Testing Procedures

• Comments to FDA on Use of Standards in FDA Regulatory Oversight of NGS Based IVDs Used for Diagnosing Germline Diseases
• Comments to FDA on Use of Public Human Genetic Variant Databases to Support Clinical Validty for NGS Based IVDs
• AMP's Analysis of FDA's Report Titled "The Public Health Evidence for FDA Oversight of LDTs: 20 Case Studies"
• AMP's Written Testimony to Hearing on "Examining the Regulation of Diagnostic Tests and Laboratory Operations"
• Laboratory Testing and Patient Care - View Video
• Comments to House E&C Committee on Regulation of In Vitro Clinical Tests Draft Legislation
• Signs from the 2014 Annual Meeting:  Are you ready to be a "manufacturer"?
• FDA's website devoted to all information relevant to the draft framework: www.FDA.gov/LDTs