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CDRH Plans Update To Procedures For Resolving Review Staff Disagreements

FDA’s device center is responding to input from HHS’ Office of Inspector General, which was outlined in a June 5 report concluding that gaps remain in processes to ensure all relevant scientific opinions are heard within CDRH.

FDA’s device center plans to issue revised standard operating procedures by the end of the month for resolving scientific disagreements between staffers, based in part on input from HHS’ Office of Inspector General.

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