Suppose you’re developing a new medical device. After thorough research, you’ve figured out your medical device classification. The regulatory pathway for your new medical technology is determined by its classification and device type and may include:
- FDA clearance through a 510(k) submission
- FDA approval via the Premarket Approval (PMA) process
- A De Novo request for device classification
- An investigational device exemption (IDE) approval to carry out a clinical study
As you prepare the FDA regulatory submission for your medical device, you may find yourself wishing you could receive targeted feedback directly from the FDA on certain aspects of your application. You’re in luck—that’s exactly what the FDA Pre-Sub program does.
In this webinar, in2being Product Development Manager Rick Routson presents an overview of the FDA Pre-Submission (Pre-Sub) program.
Through this free, voluntary program, you can ask questions about the applicability of certain standards, clinical and non-clinical studies, and verification plans.
Don’t ask questions related to topics covered by the FDA’s extensive guidance documents, such as medical device classification. If you have specific questions about your medical device classification, consider filing a 513(g) request.
A Pre-Sub request for feedback should include:
- A detailed written description of your new medical device
- Pictures and drawings of your device
- The proposed intended use of the device
- An overview of your development plans, including plans for clinical and non-clinical testing
- Your specific questions
The typical response time for a Pre-Sub is about 75 days. Once you receive the FDA’s response, you can request a meeting (in person or via teleconference) with the FDA to ask clarifying questions about their feedback.
The goal of a Pre-Sub is to streamline your premarket submission—improving the quality of your submission and shortening the FDA’s review time.
in2being partners with medical technology innovators to help them bring new medical devices to market. Contact us to find out more about our services.
If you are planning an IDE application, 501(k), or PMA submission for a new device you’re developing and have questions pertaining to some aspect of that application or submission, you may want to consider taking advantage of the FDA’s voluntary Pre-Submission, or “Pre-Sub,” program. Unlike many other FDA submission programs, there is no fee required to submit a Pre-Sub.
Pre-Subs are designed to obtain FDA’s targeted feedback to questions raised during your preparation process, which can help to ultimately streamline your future submission approval.
FDA recommends your Pre-Sub package contain a detailed description of your device, with pictures, drawings, or even samples, proposed intended use, an overview of your device development, including planned clinical and non-clinical testing, in addition to your specific questions.
Appropriate questions would include those pertaining to applicability of certain consensus standards, verification plans, and any clinical or non-clinical studies, including their proposed protocols.
However, asking FDA to advise on device classification, predicate selection, or regarding a topic covered by another published guidance, are not the intent of the Pre-Sub process and could cause rejection of the Pre-Sub.
Once submitted and accepted, the FDA will review each of your questions through its team of subject matter experts and provide a written response in approximately 75 days. If you request a follow-up meeting when submitting the Pre-Sub, either by teleconference or in-person, you will have opportunity for clarification of any of FDA’s response. Minutes of any such meeting will be taken and formally documented.
It should be noted that the Pre-Sub is not intended to be an iterative process, opening a back-and-forth stream of questions, but rather as one-time advice or response to your submitted questions.
Click on the link to access FDA’s guidance document with more details regarding the Pre-Sub submission process.
Whatever type of device or wherever you are in your development process, in2being is here to help. Contact us to learn how in2being can become your medical device development partner.