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