Originally Published MD&DI June 2008
REGULATORY OUTLOOK
Key Guidances for Diagnostic Regulations
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Guidance for Industry and FDA Staff—Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
(available at www.fda.gov/cdrh/oivd/guidance/1590.pdf)
Draft Guidance for Industry, Clinical Laboratories, and FDA Staff—In Vitro Diagnostic Multivariate Index Assays
(available at www.fda.gov/cdrh/oivd/guidance/1610.pdf)
Copyright ©2008 Medical Device & Diagnostic Industry
