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FDA Oversteps Its Bounds In Guidance On Research-Only Tests, Firms Say

This article was originally published in The Gray Sheet

Executive Summary

Diagnostics companies say recent draft guidance on research-use and investigational tests oversteps FDA’s authorities by asking firms to police how customers ultimately use these products.

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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

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