In addition to the general information that should be included in a cover letter for any Q-Sub type to ensure appropriate login and submission tracking, the following information should be included in a Pre-Sub:
Planned Follow-On Submission
Include sufficient background information and supporting documents to allow FDA to develop feedback for the Pre-Sub questions you pose. This information might include literature articles, full device description with engineering drawings, proposed labeling, videos, and/or red-lined protocol revisions depending on the specific questions for which you are requesting feedback.
A Pre-Sub should include clear, specific questions regarding review issues relevant to a planned IDE, IND, CW, Accessory Classification Request, or marketing submission to allow FDA and the submitter to focus their efforts on issues most relevant to moving a project forward. You may wish to describe your perspective on the questions you provide FDA to inform FDA’s review.
In general, FDA has found it difficult to address more than 3-4 substantial topics in a single Pre-Sub. Therefore, we recommend that you identify 3-4 substantial topics as this facilitates more productive meetings and results in more effective conversations and feedback. Additional straightforward questions (e.g. administrative topics) may be appropriate if they can be addressed without in-depth review and do not introduce new significant topics. If an excessive number of topics are included in your submission, FDA may contact you to discuss which topics you would like to focus on.
Additional guidance regarding common types of questions submitted in Pre-Subs is provided below: