There is always uncertainty baked into any government submission process, and it’s helpful to companies if there is a way to tackle issues before submitting a 510(k).
The FDA Pre-Submission is a way for companies to request feedback from the agency on potential and planned medical device, biologics, and drug submissions. It’s a great service to take advantage of, only we’ve found that it tends to get underutilized.
What is the Pre-submission?
The Pre-Submission allows you to request formal feedback on your medical device before you make a move to submit your 510(k). This is known as a Q-Submission, which under the guidance published by FDA, allows you to request the following:
- Pre-Submission (what we’re focusing on here)
- An informal meeting
- An agreement meeting
- Other (such as submission issues or study risk determinations)
The Pre-Submission process was born out of a need to provide expanded access to the FDA and allow companies to get valuable feedback ahead of time. This can help keep your company on track for getting your device to market as soon as possible — it helps to be aware of possible issues ahead of time and deal with them before final submission.
The guidance for Pre-Submission is clearly laid out in the FDA document Requests for Feedback on Medical Device Submissions. If you happen to have a combination product (such as a stent that administers a drug or an inhaler), there may be other, similar processes you need to go through. The document to check out, in that case, is Guidance for Industry.
In any case, the basic definition of what a Pre-Submission is remains the same. It is a formal written request from an applicant/sponsor for feedback from the FDA to be provided in a formal written response, meeting, or teleconference. The feedback is documented in meeting minutes.
It’s a great way to meet with the FDA, ask them some questions, then document that information for future use. It boils down to identifying key issues that keep you up at night and making your overall submission process easier.
The FDA continues to expand its Pre-Submission program to include several different medical device submissions that a manufacturer may choose to bring a device to market. The comprehensive list of submission types is known collectively as Q-Submissions(Q-Subs), which include:
E, De Novo request, 510(k), Dual, BLA, IND), Accessory Classification Request, or CW.
- Investigational device exemptions (IDE)
- Premarket approvals (PMA)
- Premarket notifications (510(k))
- HDE — Humanitarian Device Exemption
- De novo requests
- Clinical Laboratory Improvement Amendments (CLIA)
- Certain Investigational New Drug Applications (IND) and Biologic License Applications (BLAs)
Benefits of the Pre-submissions
Should I really use a Pre-Submission? This is a key question that companies often ask, so it’s important to understand the relative pros and cons. Here are some of the pros:
- You develop a “human” relationship with the FDA. They are, after all, humans themselves and want to know who you are.
- You can remove some of the risk elements from your submission. You get asked about things you don’t know and confirm things that you think you do know.
- You can get “free advice” to help drive your development and regulatory strategy.
- Sometimes the FDA will request a review of Pre-Submission materials, giving you a “bonus round” ahead of your 510(k) submission. This is a great opportunity to gain valuable feedback.
One thing to note is that you’re not getting a final acceptance at this stage; the FDA will never give you this until the actual submission. However, it’s well worth getting the early heads-up.
Cons of the Pre-submission
There’s always a money and time aspect. You’re looking at $5,000 to $25,000 to have a consultant help you with a Pre-Submission. If all timelines are met, the typical process takes 60–75 days.
A con that is frequently raised is, “What if they tell us no and say we have to do X, Y, and Z instead of what we’re already doing?”
Our answer to this will always be the same: Isn’t it better to know about this now rather than go ahead with your 510(k) submission and find out then? The FDA will pick out that same issue regardless, so it’s a much better use of your time to find out about it during a Pre-Submission.
Perhaps these cons are a big part of the reason that the Pre-Submission is underutilized, but I would strongly suggest that you don’t let them put you off using it. The FDA actively encourages medical device manufacturers to use the Pre-Submission because doing so helps the final submission's overall quality.
A Pre-Submission program is a valuable tool that tends to be underutilized. Perhaps companies are put off by the idea that the process will take too much time and money, or they’re worried that the FDA will tell them they need to do something they hadn’t already planned on doing. In Kaiyan Medical, we make sure our devices are FDA cleared and we constantly communicate with the FDA. Like many other medical device companies, you may find it’s well worth the time and money.