FDA Tweaks Q-Sub Meeting Guidance
Executive Summary
The revised guidance document clarifies the Q-submission meeting process, alternate ways sponsors may obtain FDA feedback, and more.
You may also be interested in...
FDA Seeks To Spur Innovation In Devices Designed To Treat Opioid Abuse
Draft guidance from the US Food and Drug Administration provides recommendations for the development of medical devices to treat opioid use disorder and considerations for sponsors of clinical studies to evaluate them.
US FDA Invites Comments On How It Collects Device Info Through Q-Sub Program
The US agency’s Q-Submission Program provides medical device manufacturers the opportunity to receive information on the regulatory process related to devices in development.
Final Q-Sub Guidance Describes FDA Meeting Policy
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.