Pre-Sub Presentation to FDA outline
Please prepare a presentation in MS PowerPoint for your Pre-Sub
packet to FDA on your proposed AFib Ablation Catheter.
There will only be 1 hour for this Pre-Sub meeting with FDA whether it is done face-to-face or via teleconference call. The presentation should be no more than 10 to 12 slides as you should only present for 20-30 minutes and leave enough room for the rest of the time or in-between the presentation slides for questions
and answers.
? Slide 1 should contain the title of your Pre-Sub meeting, the name of the
subject catheter, the submission date and your name and title (author).
? Slide 2 should contain the list of proposed attendees from your company. You
should also indicate if this meeting is face-to-face or via teleconference call.
Also, you have the option to submit three proposed dates and times for this
meeting with FDA as long as it is 60 days from this assignment’s due date.
Otherwise, you have the option to indicate meeting date and time “TBD” (To
be determined).
? Slide 3 should contain the list of objectives for the meeting.
? Slide 4 should contain a list of specifications for the catheter.
? Slide 5 should contain a representative picture of the catheter. Please feel free
to cut and paste pictures of the catheter from previous lecture slides.
? Slide 6 should contain a list of proposed testing as identified from the risk
analysis, along with the number of sample size for each test.
? Slide 7 should contain the proposed in vivo animal strategy.
? Slide 8 and 9 (if needed) should contain the proposed human clinical strategy.
For the items that Clinical Research department is uncertain about based on
Week 4 meeting simulation in the lecture slides, management has asked you
to incorporate and present whatever FDA recommendations you have found
on these matters, for the sake of time.
? Slide 10 should invite any questions FDA may have at the end of the meeting
or you may have for FDA.
? Slide 11 should thank FDA for their time.
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