I can not provide a template due to intellectual reasons, but I can give you a typical table of contents:
Cover Letter - simple one page
Cover Page - just a title with company name and product name
Table of Contents
1.0 Device Description - detailed device description
1.1 Introduction - what we are trying to do and want to do, regulatory pathway
1.2 Product Regulatory Information - class, regulation number, Product Code, predicate device (if known)
2.0 Proposed Indications for Use
3.0 Previous Agency Discussions - any 513(g), other Q-Sub
4.0 Overview of Performance Testing
4.1 Completed Nonclinical Performance Testing - what we have done or N/A
4.2 Completed Clinical Performance Testing - what we have done or N/A
4.3 Planned Nonclinical Performance Testing - what we are going to do
4.4 Planned Clinical Performance Testing - what we are going to do
5.0 Specific Questions for FDA
6.0 Mechanism for Feedback - face to face, teleconference, written
7.0 Exhibit - attach any exhibits (use the eCopy specification format)
Just make sure when you are writing the specific questions to FDA, you tell them what you are going to do and the questions should be more of an agreement type of question. Asking FDA open ended questions is not really going to provide you sufficient information from the feedback. Try to be as specific as possible what you are planning and if FDA agrees with the approach.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 03-Feb-2020 11:16
From: Anonymous Member
Subject: template cover letter pre-sub
This message was posted by a user wishing to remain anonymous
Hi all,
does anybody have a template for a cover letter for a pre-submission that I could use as example?
Thanks in advance