The first in a series of blogs about informal, pre-submission contact with FDA.
You are working on your submission – perhaps your first one. You have read all the guidance documents you can; you have attended several courses. But now you have a specific question on your product, your submission; a question that no guidance can answer. What do you do? Here are two simple options:
- Call or email the Premarket Programs Branch at the Division of Industry and Consumer Education (currently: 800-638-2041 or DICE@fda.hhs.gov) and ask your question. They are trained to answer all sorts of questions, but if the question is too specific (and yours probably is), they may direct you to the branch chief for your device.
- Contact the branch chief. FDA’s Office of Device Evaluation is split into divisions and then into branches. If they don’t tell you who the branch chief is or you want to contact the branch chief first, you can find the lists of branches and their chiefs here:
Look for the various “branches” under the Office of Device Evaluation or the Office of In Vitro Diagnostics and Radiological Device headings, find your best match, and send an e-mail or call the listed person.
But, if your question is very technical or you’re asking something that will require them to commit to a position (e.g., whether a certain test from a guidance document applies to your device) be prepared for this answer: “I can’t answer that via e-mail or phone. Send us a Pre-Sub.”
The Pre-Sub program
A Pre-Sub is a voluntary, written request from an applicant for informal feedback from FDA to be provided in the form of a written response or, if the applicant chooses, a meeting or teleconference. The Pre-Sub guidance includes a mechanism for getting informal feedback from FDA on a multitude of planned medical device submission types:
- Premarket Approval (PMA) application
- Premarket Notification (510(k)) Submission
- Investigational Device Exemption (IDE) application
- Humanitarian Device Exemption (HDE) application
- Evaluation of Automatic Class III Designations (de novo petition)
There are other informal meetings referenced in the guidance, such as “Informational Meetings”. All of these written requests fall within the same organizational structure and are collectively referred to as Q-Submissions, or “Q-Subs” after the “Q-number” that is assigned to each request.
There are no user fees associated with a Pre-Sub. The process is intended to provide applicants with the opportunity to obtain targeted FDA feedback in response to specific questions. Some examples of targeted questions that are appropriate to ask during a Pre-Sub meeting are:
- Do you agree with our test matrix?
- Here is our risk analysis, do you agree that we’ve captured everything?
- Does the FDA agree with the use of the proposed alternative test method, which is different than the normally recognized standard?
- Are the proposed clinical trial design and selected control group appropriate?
- Can you give us your input on our primary endpoint and hypothesis for our clinical study?
We frequently stress the importance and the value of involving regulatory strategy experts early and often during the development of a new medical device. A regulatory strategy for a novel medical device will often include a Pre-Sub meeting to address a specific area of concern. These early interactions can smooth the preparation of the subsequent submission, minimize deficiency questions that can draw out the approval process, and foster collegial relationships with the regulators. MED has a long history of successfully navigating these types of interactions with the FDA.
For more information, please visit our website at http://www.medinstitute.com.
Next time: When should you take advantage of the Pre-Submission program?