I’ve said it time and time again – the FDA pre-submission is a valuable tool for companies seeking FDA approval for their medical devices. But far too many manufacturers opt not to take advantage of this golden opportunity to get in front of the FDA and ask very specific questions that can refine your submission strategy.
An FDA pre-submission will benefit any medical device manufacturer, but it’s especially beneficial to companies with novel or first-of-its-kind devices, companies who can’t decide on the appropriate regulatory pathway, or companies looking for specific feedback on certain aspects of their device or technology.
But Michelle, why would I bother with a pre-sub when I’ve already chosen my submission pathway?
Oh, I was hoping you’d ask that question.
An FDA pre-submission helps you craft the story that will inform FDA about your device, familiarizing them with your technology and helping them formulate a position for their review. It’s also your chance to ask specific questions about your regulatory plan, your performance testing plan, your clinical study plan, and your protocols.
Here’s a few more good reasons to schedule a pre-sub:
- A pre-sub gets the FDA involved early, which helps ensure your device aligns with their expectations and avoids surprises later in the submission process.
- A pre-sub can identify potential roadblocks or regulatory hurdles your device might face, allowing you to address them proactively – rather than reactively later on down the road.
- A pre-sub helps refine your regulatory strategy: The FDA’s feedback can help you determine the most appropriate regulatory pathway (e.g., 510(k), De Novo) for your device.
Did I mention that the pre-sub is FREE? So, you’ve really got nothing to lose and a whole lot to gain from participating in the process. The return on an FDA pre-submission is usually very quick, as the agency typically send written feedback within 70 days. And while the FDA’s feedback from a pre-sub is not binding, they will usually hold that stance as long as your device doesn’t change significantly between pre-sub and formal submission.
How to Prepare for a Pre-Submission
There’s an art to preparing questions for your FDA pre-submission. You want to focus on 3-4 critical topics that are key for moving the project forward and limit yourself to 1 or 2 questions per topic. You want to be sure that your questions are clear and objective, avoiding open-ended questions and focusing on getting the FDA’s concurrence on specific issues. You also want to be sure to provide enough supporting documentation to back up your questions.
The FDA offers a free online tool called Pre-Star to help you create and submit pre-submissions electronically. Pre-Star offers features like:
- Automated guidance document recommendations: Pre-Star suggests relevant guidance documents based on your device information.
- Error checking: Pre-Star helps ensure your submission is complete and avoids inconsistencies.
Pre-Star doesn’t have great built-in features for collaborative editing, so having people from multiple departments enter information might be tricky. And there’s limited space, so be ready to summarize longer sections of text into a shorter paragraph or bullet list.
After the pre-sub, it’s just a matter of waiting for FDA response, and there are several ways to receive that feedback:
- You can accept written feedback only. This is a good starting point to get a comprehensive response from the FDA, AND you’ll have hard-copy documentation to refer to later (or use in your formal submission).
- You can request a teleconference, which allows for a more interactive discussion but may require more preparation.
- You can request an in-person meeting, which offers the most opportunity for in-depth discussion with FDA but is limited to 60 minutes and cannot be recorded.
Bear in mind that the FDA is bringing on board a lot of new reviewers, and they are not always up to speed on all of the applicable guidance documents. It’s possible that you could receive feedback that actually contradicts what is in those guidance documents and doesn’t follow documented FDA policy. This is where you may need to escalate and get the reviewer’s supervisor and/or the FDA client ombudsman involved.
Some other things to consider:
- Maintain a timeline: The FDA follows a set timeline for pre-submissions. Be prepared to meet deadlines for questions, meetings, and feedback review.
- Don’t hide past pre-submissions: The FDA keeps track of all your pre-submissions. Be upfront about any previous interactions, because the FDA never forgets.
- 513(g) requests vs. Pre-Submissions: 513(g) requests are similar to pre-submissions but focus on getting a designation for your device and come with a fee. They are a good option if you struggle to find a suitable predicate device.
The FDA pre-submission is a powerful tool for companies navigating the FDA medical device approval process. By understanding the process, knowing how to prepare, and what tools are available to help, you can increase your chances of a successful FDA submission.
Want to learn even more? Check out my recent Master Class on FDA pre-submissions.
Or read about some other common submission pathway pitfalls I’ve seen over the course of my career.
