FDA Time Frames (Device) RAC UPDATED Exam Questions and CORRECT Answers
3 views 0 purchase
Course
FDA Time Frames RAC
Institution
FDA Time Frames RAC
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...
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
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 MGRADES. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $7.99. You're not tied to anything after your purchase.