AdvaMedDx Priorities for Diagnostics Regulatory Reform
Member-Exclusive Resource
The diagnostics regulatory landscape is at a turning point. This member-exclusive resource breaks down AdvaMedDx’s core priorities for a modernized, risk-based framework governing all in vitro diagnostic tests and technologies — and unpacks the VALID Act, the landmark legislation reshaping how IVDs and LDTs would be regulated under the FDCA.
Inside, you’ll find a clear breakdown of the four proposed regulatory pathways — Exemption, Technology Certification, Special Premarket Review, and Full Premarket Review — and what each would mean for developers bringing diagnostic innovations to market. Whether you’re tracking policy developments or need a quick reference for internal briefings, this guide gives you the essential context in one place.
Download now to get AdvaMed’s authoritative take on where diagnostics regulation is headed.