What is a Pre-Submission?
The pre-submission process is an opportunity for you to engage with FDA before submitting the official (costly) 510(k). Although not mandatory, we highly suggest using the FDA’s pre-submission option to acquire feedback straight from the source. Especially if your technology is novel in methodology or design!
When properly used as part of a regulatory strategy, any issues with your device or your FDA submission documents can be discovered and corrected – saving you from wasting valuable time and money on additional 510(k) submission attempts.
Pre-Submissions are FREE FREE FREE!
Did We Mention That FDA Doesn’t Charge for Pre-submissions?!
While the process for a 510(k) can get very expensive (especially if you require multiple 510(k) submissions, or a de novo 510(k) ), the FDA’s pre-submission is completely free to file.
Who Should File a Pre-Submission?
Really, there is no harm in filing a pre-submission, so anyone with a 510(k) in their future can benefit from going through the process. Those with particularly complicated medical devices can benefit most from completing a pre-submission. That being said, a pre-submission should be treated like an interview with FDA. It’s important to have regulatory experts, like the leanTeam, prepare the pre-submission and shape the conversation to be in your favor.
Adding the pre-submission process to your regulatory strategy provides additional time for the FDA to understand your technology – without the added pressure of having to determine if your device is safe and effective, the ultimate goal of the 510(k). Occasionally, special circumstances, including particularly complicated devices, benefit from multiple pre-submissions, and I think we can all agree that multiple free pre-submissions are better than multiple costly, stressful 510(k) submissions.
Are Pre-submissions Worth It?
In our (very expert) opinion, yes. But here, let us tell you about why we think opting for a pre-submission in your regulatory strategy is worth it, and you can come to your own conclusion.
Pre-submissions offer:
An opportunity to discuss specific questions regarding your device
Early introduction of your device to the FDA
Insight into the FDA’s areas of focus
Opportunities for FDA alignment
Possible shortening of the 510(k) process by working out the kinks beforehand
Even though pre-submissions are technically non-binding, the FDA publicly states its intention to honor pre-submission feedback and rarely changes its guidance suggestions.
What Aspects Are In a Pre-submission?
The pre-submission is a fairly comprehensive process that covers
Clinical protocol feedback
Performance testing protocols
Predicate strategy
And more!
Regulatory Pre-submission Options
Depending on what works best for your needs, you can choose to interact with the FDA during the pre-submission process through teleconference meetings or written feedback. Either option has its pros and cons, some of them being:
Teleconference
Written Feedback Only
If you reviewed our handy dandy table and are still thinking, “I have no idea what to do here,” the first thing you need to do is take a deep breath. The second (and only other) thing you need to do is talk to leanRAQA. We can help you create a regulatory strategy that involves every detail, including what method of contact with the FDA will benefit your goals the most.
Let’s Check “Pre-submission” Off Your To-Do List
Have we convinced you that a pre-submission will benefit your regulatory strategy? Then let’s start working together on bringing your medical device to market.
While the pre-submission process may sound relatively simple, those who are novices in the RAQA realm can still easily get lost in the numerous required steps and make avoidable mistakes. For example, although it may seem like a good idea to jump straight to filing your pre-submission just to get the FDA clock started and because it won’t cost you any money, this method could cost you in other ways. If your regulatory submission documents are not ready for FDA review, seeing the first drafts could cheapen your device in their eyes. The FDA never forgets previous formal feedback, so any negative points could cast a shadow over your device that stays with it forever.
Instead of taking your chances for possibly doing this all the right way or making grave mistakes, why not get expert help in the matter? You wouldn’t go to court without a lawyer, right? So why go to the FDA without our expert advisors on your side?
Put some time on my calendar. Let’s talk.
Two Submission Pathways Diverge in a Wood…..Do You Know Which Path to Take?
Download my FREE Regulatory Pathway Assessment tool, which walks you through the specifics of choosing a regulatory submission pathway.
Then pick an open half hour on my calendar and we can chat about your regulatory submission needs.
