Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
CDRH issues simplified SOPs for resolving differences of scientific, regulatory or clinical opinion among staffers. More regulatory news.
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Regulatory News In Brief
ORA reorganizes, and HHS’ Office of Inspector General plans investigations of FDA programs. More regulatory news.
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.
Device Center Discord: 510(k) Review Process Is Flash Point At 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