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DEVICE CEASE DISTRIBUTION/NOTIFICATION ORDER PROCEDURES ALLOW FOR 11th-HOUR NEGOTIATIONS UNDER MANDATORY RECALL RULE; REG ADDS FDA ACTION DEADLINES

This article was originally published in The Gray Sheet

Executive Summary

Device companies will have an opportunity prior to receipt of an FDA cease distribution and notification order to enter informal negotiations with the agency to make a case for stopping the procedures, according to a final rule on mandatory device recalls.

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