Question
Answer
Explanation
What type of meeting request is used to share information with
FDA without the expectation of feedback from them?
A. Pre-Sub Meeting
B. Informational Meeting
C. Submission Issue Request (SIR)
D. Study Risk Determination Meeting
B. Informational Meeting
RAC Book page 101.
An Informational Meeting allows sponsors to share
information with the FDA, typically about device
development, without expecting feedback. These
meetings can help familiarize FDA reviewers with new
technology or ongoing projects.
In how many days should Q-Sub meeting minutes be provided to
FDA after the meeting has taken place?
A. 10 days
B. 15 days
C. 20 days
D. 30 days
B. 15 days
What type of meeting request is used to share information with
FDA without the expectation of feedback from them?
A. Pre-Sub Meeting
B. Informational Meeting
C. Study Risk Determination
D. Submission Issue Request (SIR)
B. Informational Meeting
In what format must Q-Subs be submitted?
A. Paper Submission
B. eCopy
C. Email Submission
D. CD-ROM
B. eCopy Explanation: Under section 745(A)(b) of the FD&C Act,
Q-Subs must be submitted in eCopy format.
What is a Q-Sub supplement?
A. A completely new request for FDA feedback.
B. Any new request for feedback related to an existing Q-Sub.
C. An amendment to the original Q-Sub.
D. A regulatory filing unrelated to the original Q-Sub.
B. Any new request for feedback related to
an existing Q-Sub.
Explanation: A Q-Sub supplement involves seeking
feedback on the same or similar device as the original Q-
Sub.
What is a Q-Sub amendment?
A. A new Q-Sub request.
B. A request for meeting minutes.
C. Additional information related to the original Q-Sub.
D. A revised classification request.
C. Additional information related to the
original Q-Sub.
What is the Pre-Sub method of feedback and timeframe?
A. Written feedback only, 45 days.
B. Meeting with FDA, 90 days.
C. Written feedback or meeting, 70 days.
D. Meeting only, 60 days.
C. Written feedback or meeting, 70 days.
