FDA Time Frames (Device) RAC Exam | 100% Correct | Verified | Latest Update 2024

Facility Registration - Devices - within XX days of application or manufacturing - 30 days Facility Re-Registration - Devices, Drugs & Biologics - Annual GLP & GCP Record Retention - 5 Years - from application or 2 Years - from approval or termination date IND/IDE (GCP) - Progress Report - Reporting requirements Sponsor report to FDA & IRB Investigator reports to Sponsor & IRB - Annual - 60 days from anniversary IND & IDE - time allowed to FDA notification - Beyond which OK to start investigation - 30 days IND/IDE AE - Unanticipated - present unreasonable risk - Termination of study (by GCP) - 5 WORKING days from determination, but no later than 15 days after learning of adverse effect IDE - Unanticipated AE - Sponsor to FDA & IRB