Multiplex

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New Draft Guidance for Multiplex Tests Elizabeth Mansfield and Michele Schoonmaker Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) CDRH/FDA

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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]

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]

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]

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Multiplex

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 New Draft Guidance for Multiplex Tests Elizabeth Mansfield and Michele Schoonmaker Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) CDRH/FDA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

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12. Regulatory Strategies

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19. Problem areas

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Multiplex

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Multiplex