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New Draft Guidance for Multiplex Tests Elizabeth Mansfield and Michele Schoonmaker Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) CDRH/FDA
[object Object],[object Object],[object Object],[object Object],[object Object],Draft Multiplex Guidance
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[object Object],[object Object],[object Object],Major Points
Technical Issues in Multiplex Test Validation
Intended Use ,[object Object],[object Object],[object Object]
Platform Design and Manufacturing ,[object Object],[object Object],[object Object]
Test Design: Pre-analytical ,[object Object],[object Object],[object Object]
Specific performance characteristics ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Array and data processing ,[object Object],[object Object],[object Object],[object Object]
Instrumentation ,[object Object],[object Object],[object Object],[object Object]
Regulatory Strategies
510(k): Class II devices ,[object Object],[object Object],[object Object],[object Object],[object Object]
PMA: Class III devices ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
De novo 510(k) ,[object Object],[object Object],[object Object]
Pre-IDE (protocol review) ,[object Object],[object Object],[object Object],[object Object],[object Object]
Clinical Effectiveness ,[object Object],[object Object]
Use of Literature ,[object Object],[object Object],[object Object]
Problem areas
Study Design ,[object Object],[object Object],[object Object]
Statistical Methods ,[object Object],[object Object]
Quality Control ,[object Object],[object Object],[object Object]
Regulatory Environment ,[object Object],[object Object],[object Object]
Your role ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Future Directions ,[object Object]

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