Efforts to Allow FDA Oversight of Clinical Laboratory-Developed Tests Continue in New Congress

Apr 21, 2023 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Testing, Pathology and Clinical Laboratory Conferences

The VALID Act has been refiled and the FDA has declared its intent to issue a proposed rule to enable it to oversee LDTs Should the federal Food and Drug Administration (FDA) have the authority to regulate laboratory-developed tests (LDT)? Advocates in favor of this outcome are working to make FDA oversight of LDTs a reality. On March 29, HR.2369—the Verifying Accurate Leading-edge IVCT Development Act of 2023 (VALID Act)—was refiled in the US House of Representatives by Representatives Larry...

Congress Holds Off on Enabling FDA Regulation of Clinical Laboratory-Developed Tests

Feb 27, 2023 | Compliance, Legal, and Malpractice, Laboratory Pathology, Laboratory Resources, Laboratory Sales and Marketing, Laboratory Testing

Supporters of the VALID Act say lobbying blitz by academic medical centers prevented its passage In 2022, a bill before Congress titled the Verifying Accurate Leading-Edge IVCT Development Act (VALID Act) sought to change the current regulatory scheme for clinical laboratory-developed tests (LDTs) and in vitro clinical tests (IVCTs). But even though the College of American Pathologists (CAP) and nine other organizations signed a December 12 stakeholder letter to leaders of key House and Senate...
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