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Makers Of Research-Only Tests Must Respond To Inappropriate Use – FDA Draft Guidance

This article was originally published in The Gray Sheet

Executive Summary

Diagnostics makers can be held responsible for inappropriate, clinical use of tests labeled for investigational or research use only, if they are aware of it, FDA says in new draft guidance.

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Knowledge Is Not Enough For Enforcement In FDA’s Final Research-Use Dx Guidance

Companies are at risk of enforcement if they take direct steps to encourage use of their research-use or investigational-use only tests for clinical diagnostic indications, according to the guidance. But, in response to public comments, FDA removed references that a company knowing or having “reason to know” that a lab is inappropriately using a test is grounds for enforcement.

Knowledge Is Not Enough For Enforcement In FDA’s Final Research-Use Dx Guidance

Companies are at risk of enforcement if they take direct steps to encourage use of their research-use or investigational-use only tests for clinical diagnostic indications, according to the guidance. But, in response to public comments, FDA removed references that a company knowing or having “reason to know” that a lab is inappropriately using a test is grounds for enforcement.

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