In Brief: CDRH Class I recall authority
This article was originally published in The Gray Sheet
Executive Summary
CDRH Class I recall authority: Associate Commissioner for Regulatory Affairs Ronald Chesemore delegates to the Center for Devices and Radiological Health authority to classify Class I recalls, according to Sept. 3 memo. CDRH Director Bruce Burlington and "CDRH personnel having authority" may now classify Class I recalls instead of forwarding recall recommendations to the Office of Regulatory Affairs for final sign-off...