FDAnews Device Daily Bulletin

FDA Imposes IRB Sanction, Citing Review, Documentation Failures

April 20, 2010
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The FDA has stopped enrollment in ongoing device studies reviewed by the Genetics & IVF Institute institutional review board (IRB) because of continuing review, expedited review and record-keeping failures. The agency will lift the sanction once the Fairfax, Va., IRB demonstrates it has taken adequate corrective actions, according to a Dec. 23 warning letter posted last month. The IRB has submitted a corrective action plan, but the FDA must confirm it, Genetics & IVF Institute spokeswoman Trina Leonard said. Because the implementation of the proposed plan is ongoing, the IRB is still not reviewing or approving new studies, she added.
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