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What content is expected to be included within a Pre-Submission?

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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

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

Clearly indicate what type of future submission (IDE, IND, CW, Accessory Classification Request, or marketing submission) is the focus of your Pre-Sub questions to help direct FDA’s feedback.

Background Information

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.  

Specific Questions

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:

  • Study Protocols: Note that resource constraints do not permit FDA to prepare or design particular study plans. If a submitter would like FDA’s feedback on a protocol, they should submit a proposed outline, with a rationale for the chosen approach.
    If the Pre-Sub is for a nonsignificant risk device study, IDE exempt device, CW, Dual, or a study you plan to conduct outside the US (OUS) to support a marketing submission, the submitter should consider submitting the entire protocol through the Pre-Sub process prior to initiating the study, particularly if it raises unique scientific or regulatory considerations.
  • Review of Data: Requests for a pre-review of data are generally not appropriate for the Pre-Sub program. However, if the data and conclusions are difficult to interpret, it may be appropriate to ask a specific question regarding the interpretation of preliminary results or the planned approach for addressing the results within the upcoming submission.
  • Regulatory Approach: Note that under the Pre-Sub program, FDA is able to provide feedback regarding regulatory strategy and approach. For example, whether a cleared 510(k) device or granted De Novo has the potential to serve as a predicate for a proposed device and indications for use. A formal written request for classification of a device and indications for use requires a 513(g) Request for Information.

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