The document summarizes a draft guidance from the FDA for regulating multiplex tests. It discusses several key points including that the FDA will take a risk-based approach to determining regulatory paths for multiplex tests and does not consider them to be analyte specific reagents. The draft provides recommendations on validation of intended use, platform design, test design, performance characteristics, data analysis, and appropriate regulatory strategies depending on risk classification. It seeks input on challenges like study design and statistical methods for rare samples and multiple intended uses.

1. New Draft Guidance for Multiplex Tests Elizabeth Mansfield and Michele Schoonmaker Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) CDRH/FDA

5. Technical Issues in Multiplex Test Validation

12. Regulatory Strategies

19. Problem areas