CAP Advocacy promotes a favorable, effective regulatory environment through its engagement with the Congress, Food and Drug Administration (FDA), Centers for Medicare & Medicaid Services (CMS), and other industry groups for a sensible public-private oversight to ensure the quality and accuracy of laboratory-developed tests (LDTs).
While the FDA did not finalize its proposed LDT oversight guidance document, the agency did release a discussion paper on LDTs. The CAP continues to advocate for its principles for LDT oversight, which formed the CAP’s LDT framework first presented to the FDA and other stakeholders in 2009 and also captured in the CAP’s legislative proposal. The CAP believes any regulatory framework for LDTs must enhance patient safety, maintain quality laboratory testing, and promote innovation without creating a significant new regulatory burden on laboratories.
Legislative Proposal for LDT Oversight
- Legislative Proposal for Oversight of LDTs (PDF, 240 KB)
- LDT Oversight Frequently Asked Questions (PDF, 65 KB)
- CAP Letter to the House Energy and Commerce Committee (June 19, 2015) (PDF, 148 KB)
- Laboratory Medicine Groups' Comments on Continuing Engagement with the FDA on a Proposed Oversight Framework (September 15, 2010) (PDF, 79 KB)
Comments to FDA
- Draft Guidance Framework for Regulatory Oversight of LDTs (February 2, 2015) (PDF, 551 KB)
- Oversight of LDTs (PDF, 160 KB)
- FDA Research Use Only Guidance (PDF, 270 KB)