FDA Time Frames (Device) RAC Exam Questions and Answers 100% Verified
11 views 0 purchase
Course
FDA Time Frames RAC
Institution
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
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller NursingTutor1. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $11.99. You're not tied to anything after your purchase.
