What is a pre-sub?
The FDA offers medical device companies an opportunity to meet and discuss their device during the development process before a regulatory submission. This is called a pre-sub and is available as part of FDA's Q-submission program. FDA has specific guidance on pre-subs so you can make the most out of your meeting. These meetings are useful for multiple reasons, including asking specific questions about your device's regulatory pathway, investigational device exemption (IDE) applications, planned marketing claims, pre-clinical testing you plan to perform, and applicable standards. As a side note, pre-sub meeting applications and investor updates on pending FDA meetings is a great way to show your existing and potential investors that you are de-risked from a regulatory perspective. We will have an entire post on this later (BGP-41).
What to include in your pre-sub package
The usefulness of pre-sub meetings depends on what you include in your pre-sub package. A pre-sub starts with you submitting a formal request to FDA for feedback. Device Description, Indications for Use, and Intended Use are the most useful documents to provide if they are set. Be careful to not limit yourself here as the FDA will expect the device to be in the area you determined. Any pivots after a meeting should be conveyed to the group to ensure they are aware of the changes to expect. FDA will provide written feedback, and will meet in person or via teleconference if you choose. Be sure to include specific questions in your pre-sub package - FDA will respond to your specific questions but won’t offer unsolicited feedback. Some of the most useful questions include questions with yes or no answers - like “Does FDA agree with our device classification?”
What to do during your meeting
Before your meeting, you will receive written feedback from the FDA. If you still want to meet after receiving your written feedback, you should create a slide deck introducing your team, device, and the specific topics you'd like to discuss, and have it ready a few days before your scheduled meeting. Your meeting is your time to request any clarification on FDA’s written feedback, provide your responses to any of their questions, and engage in discussions about your specific questions. If you receive your feedback with sufficient time to respond with questions, you should take advantage of this. Clarifications and additional material to address questions would only allow you to ask more questions that are critical in the phone meeting instead of addressing confusions.
What to NOT do during your meeting
Don’t introduce brand-new information during your pre-sub meeting. FDA based their responses on information you provided in your pre-sub package, so any changes to your product that you’ve made since your submission must be addressed. Don’t make an adversary of the FDA during your meeting - if you don’t agree with their feedback, respectfully ask for more information about how they reached their decision.
What to do after your meeting
As part of the pre-sub process, you are responsible for submitting meeting minutes. You can find an example of meeting minutes in the appendix of FDA's guidance document for pre-subs. FDA will review your minutes, and they will get appended to the pre-sub package you submitted. You can reference your pre-sub package and meeting minutes in future submissions - this helps keep FDA in the loop about your product development.
Pre-subs are one strategy Nemedio recommends to accelerate the development of your medical device - reach out and see how we can help you prepare your pre-sub!