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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.

FDA final guidance signals plans to step up enforcement of companies that sell a test to labs for clinical diagnostic applications even though the test is labeled only for research. But the guidance, issued Nov. 25, removes language from a 2011 draft version

that had troubled diagnostics firms because it appeared to put the onus on them to police the activities of their lab customers.

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