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FDA Time Frames (Device) RAC Exam Q&A Latest Update 2025
Course:
RAC
Institution:
RAC
FDA Time Frames (Device) RAC Exam Q&A Latest Update 2025
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| Uploaded on: | April 28, 2025 |
| Last updated: | May 17, 2025 |
| Number of pages: | 5 |
| Written in: | 2025/2026 |
| Type: | Exam (elaborations) |
| Contains: | Questions & Answers |
| Tags: | FDA Time Frames (Device) RAC Exam Q&A Latest Update 2025 |
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FDA Time Frames (Device) RAC Exam | Q&A Latest 2025/2026 | 100% PASS Facility Registration - Devices - within XX days of application or manufacturing - Answer -30 days Facility Re-Registration - Devices, Drugs & Biologics - Answer -Annual GLP & GCP Record Retention - Answer -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 - Answer -Annual - 60 days from anniversary IND & IDE - time allowed to FDA notification - Beyond which OK to start investigation - Answer -30 days IND/IDE AE - Unanticipated - present unreasonable risk - Termination of study (by GCP) - Answer -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 - Answer -10 WORKING days
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