FDA Time Frames (Device) RAC Exam 2026

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FDA Time Frames (Device) RAC Exam

1. Facility Registration - Devices - within XX days of application or manufac- turing: 30 days 2. Facility Re-Registration - Devices, Drugs & Biologics: Annual 3. GLP & GCP Record Retention: 5 Years - from application or 2 Years - from approval or termination date 4. IND/IDE (GCP) - Progress Report - Reporting requirements Sponsor report to FDA & IRB Investigator reports to Sponsor & IRB: Annual - 60 days from anniversary 5. IND & IDE - time allowed to FDA notification - Beyond which OK to start investigation: 30 days 6. 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 7. IDE - Unanticipated AE - Sponsor to FDA & IRB IDE - Unanticipated AE - Investigator to Sponsor and IRB: 10 WORKING days 8. IDE - Deviation from Investigational Plan (including Informed Consent) - Sponsor to FDA & IRB IDE - Deviation from Investigational Plan (including Informed Consent) - Inves- tigator to Sponsor and IRB: 5 days 9. 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 10. IDE - Current Investigator's List: 6 months Device only • Current investigator list: Provide FDA, at 6 - month intervals, a current list of names/addresses of all investigators participating in the investigation (812.150(b)(4)) 11. IDE - Final report from completion or termination: 3 months

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