Medtech Insight

Final Q-Sub Guidance Describes FDA Meeting Policy

08 May 2019

A new final guidance document from the US FDA explains how the agency wants device developers to use its Q-Submission Program to get agency feedback outside the formal product submission process.

Group of business people having a late night video conference meeting. Sitting around a conference table talking and networking. - Image

Device developers looking for additional information on how to best communicate with the US Food and Drug Administration before making a product submission have a new final guidance document to rely on.

The 7 May document, "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program," was issued in draft form in June 2018 and fulfills a MDUFA IV...