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FDA Time Frames (Device) RAC UPDATED Exam Questions and CORRECT Answers $7.99   Add to cart

Exam (elaborations)

FDA Time Frames (Device) RAC UPDATED Exam Questions and CORRECT Answers

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FDA Time Frames (Device) RAC UPDATED Exam Questions and CORRECT Answers Facility Registration - Devices - within XX days of application or manufacturing - Correct Answer- 30 days Facility Re-Registration - Devices, Drugs & Biologics - Correct Answer- Annual GLP & GCP Record Retention - Corr...

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  • August 9, 2024
  • 4
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers
  • FDA Time Frames RAC
  • FDA Time Frames RAC
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MGRADES
FDA Time Frames (Device) RAC
UPDATED Exam Questions and
CORRECT Answers

Facility Registration - Devices - within XX days of application or manufacturing - Correct
Answer- 30 days


Facility Re-Registration - Devices, Drugs & Biologics - Correct Answer- Annual


GLP & GCP Record Retention - Correct 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 - Correct Answer- Annual - 60 days from anniversary


IND & IDE - time allowed to FDA notification - Beyond which OK to start investigation -
Correct Answer- 30 days


IND/IDE AE - Unanticipated - present unreasonable risk - Termination of study (by GCP) -
Correct 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 - Correct Answer- 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 - Correct Answer- 5 days

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