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FDA Time Frames (Device) RAC Exam Questions and Answers 100% Verified $11.99   Add to cart

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FDA Time Frames (Device) RAC Exam Questions and Answers 100% Verified

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FDA Time Frames (Device) RAC Exam Questions and Answers 100% VerifiedFDA Time Frames (Device) RAC Exam Questions and Answers 100% VerifiedFDA Time Frames (Device) RAC Exam Questions and Answers 100% VerifiedFDA Time Frames (Device) RAC Exam Questions and Answers 100% VerifiedFacility Registration -...

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  • September 29, 2024
  • 7
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers
  • FDA Time Frames RAC
  • FDA Time Frames RAC
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NursingTutor1
FDA Time Frames (Device) RAC

Exam Questions and Answers

100% Verified


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




PDP Protocol - acceptance by FDA - ANSWER-120 days or as agreed




PDP - Product Approval by FDA after completion of protocol - ANSWER-90

days




Real-time review of PMA supplement - Acceptance of real time method by

FDA - ANSWER-5 days

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