Regulatory News In Brief
This article was originally published in The Gray Sheet
CDRH issues simplified SOPs for resolving differences of scientific, regulatory or clinical opinion among staffers. More regulatory news.
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ORA reorganizes, and HHS’ Office of Inspector General plans investigations of FDA programs. More regulatory news.
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.
Details trickling into the public sphere about CDRH's device review process reveal heightened tension between reviewers and management over the proper response to a 510(k) submission