FDA Removes Firms’ Responsibility To “Know” In Research-Use Only Final Guidance-graysheet: FDA final guidance (PDF) outlines 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. The guidance, titled “Distribution of In Vitro Diagnostic Products Labeled for Research-Use Only or Investigational-Use Only,” tries to make clear that companies are at risk of enforcement if they take direct steps, in any way, to encourage use of their research-use or investigational-use only tests for clinical diagnostic indications.
