FDA Time Frames (Device) RAC Exam 2024 | 35 Questions with 100% Correct Answers | Verified | Latest Update 2024| Graded A+

FDA Time Frames (Device) RAC Exam 2024 | 35 Questions with 100% Correct Answers | Verified | Latest Update 2024| Graded A+ 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 IDE - Unanticipated AE - Investigator to Sponsor and IRB - 10 WORKING days IDE - Deviation from Investigational Plan (including Informed Consent) - Sponsor to FDA & IRB IDE - Deviation from Investigational Plan (including Informed Consent) - Investigator to Sponsor and IRB - 5 days IDE - Withdrawal of IRB approval - Sponsor to FDA & IRB + Investigators IDE - Withdrawal of IRB approval - Investigator to Sponsor & IRB IDE - Withdrawal of FDA approval - Sponsor to IRB + Investigators IDE - Withdrawal of FDA approval - Investigator to Sponsor & IRB - 5 days