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Home 5 Articles 5 Laboratory Developed Test Regulatory Reform Moves Closer to Reality

Laboratory Developed Test Regulatory Reform Moves Closer to Reality

by | Jun 15, 2022 | Articles, Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, Legislation-dtet

Newly proposed legislation would establish a risk-based regulatory system for LDT regulation, though not everyone is happy with it.

A closeup of a lab worker loading a blood sample into a machine for testing stock image
Like previous incarnations, the new VALID Act would establish formal FDA oversight of IVCTs, including premarket review, registration and listing, test design and quality, labeling, adverse events, and corrections and removals.

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