CDRH Industry: Administrative Procedures for CLIA Categorization - Guidance for Industry and Food and Drug Administration Staff

Administrative Procedures for CLIA Categorization, a guidance for Industry and Food and Drug Administration Staff, has recently been posted.  This guidance is updated to include information regarding FDA’s internal administrative processes, including CDRH’s e-copy program which is voluntary for CLIA categorizations.  For more information, please see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070762.htm