ODE software reviewer's guide to return to policy based on three levels of concern.
This article was originally published in The Gray Sheet
ODE SOFTWARE REVIEWER GUIDE TO RETURN TO THREE LEVELS OF CONCERN, Donna-Bea Tillman, Software Coordinator in FDA's Office of Device Evaluation, FDA's Center for Devices and Radiological Health, said at the recent Regulatory Affairs Professional Society conference in Washington, D.C.
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