Hepatitis diagnostic, monitoring test jurisdiction moved to CDRH from biologics center.
This article was originally published in The Gray Sheet
HEPATITIS DIAGNOSTIC, MONITORING TEST JURISDICTION SWITCH TO CDRH has been implemented in response to petitions by in vitro diagnostics manufacturers to FDA's Office of the Ombudsman. The Center for Biologics Evaluation and Research, which had been reviewing applications for Hepatitis B and C diagnostic and monitoring tests, will continue to review tests for hepatitis blood screening indications.
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