Knowledge Is Not Enough For Enforcement In FDA’s Final Research-Use Dx Guidance
This article was originally published in The Gray Sheet
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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