News

New update for FDA SOP on resolving conflict on regulatory decisions

10/15/12

CDRH has posted a new version of the standard operating procedures protocol to resolve differences in opinion that occur in regulatory decisions. This document is updated from the 2009 document in order to harmonize this procedure with other guidances and SOPs.

To read this document: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOmbudsman/UCM183860?source=govdelivery