The last in a series of blogs about informal, pre-submission contact with FDA. Visit our website for the previous six.
The Pre-Sub process can be time-consuming (Pre-Sub; see FDA guidance here). You may wonder if it’s worth it. We discussed some of the reasons for having a Pre-Sub (or not having one) in a previous post, but let’s look at those again:
- Is the device new (to you) or FDA?
- How well do guidance documents, recognized consensus standards, or 510(k)/PMA summaries apply?
- Where are you in the development cycle?
- How expensive is it to be wrong?
Those are the “hard” questions to ask before you decide, but there are a few more “soft” reasons for asking for a Pre-Sub:
- It is a valuable opportunity to make a good first impression.
- It is a great way to sort out major issues in a non-adversarial manner.
- It is a great way to educate FDA on your new device, technology, or test.
This last one is especially important. You may have 100% confidence in your development program. But if FDA has never seen this type of device before, it is helpful if they are exposed to it proactively. The back-and-forth of the Pre-Sub program gives you time to explain your device before your formal submission, when table upon table of data arrive at their doorstep unannounced.
MED believes it is important to integrate your engineering and regulatory strategies from the very beginning of the medical device development process, if possible, or at least as early in the process as you can. The Pre-Submission (Pre-Sub) process is a perfect opportunity to present both your engineering strategy and your regulatory strategy to FDA early in the process and ensure that everyone is in agreement.
We all have the same goal: to help patients by providing innovative and safe medical devices. Keeping this common goal in mind during our interactions will help us to focus on the supporting data and risk mitigation tools that support that goal. We can also develop trust and foster meaningful relationships with the agency in the process.
To have a more thorough discussion or to answer any questions you may have regarding the Pre-Sub process or tips on how to effectively communicate with FDA, please contact MED Institute via our website at http://www.medinstitute.com