This video is part of an ongoing series of “droplet” videos intended to communicate key concepts in the medical device development process.
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.