Early Communication with the FDA

Let’s face it - communicating with the FDA can be intimidating. But it doesn’t have to be. If you know where to find vital information on your own, as well as when and how to reach out to the FDA, the process is more efficient and effective. Emergo consultants have years of experience corresponding with the FDA, so we know what works and what doesn’t. Discover our tricks of the trade in this white paper, with guidelines, tips, and other useful information to help you feel more confident corresponding with the FDA about the clearance of your medical device.

In this white paper, you will learn:

• When is it appropriate to contact the FDA?
• Why should you contact the FDA?
• Who should you contact and how do you contact them?
• What informational resources does the FDA provide?
• Which guidance documents published by the FDA describe the process of contacting the FDA to receive their feedback?
• What is a “Q-Sub”/”Pre-Sub”?

We answer all of these questions and more in this 5-page white paper.

About the Author:
Audrey Swearingen is a Senior Global Regulatory Consultant with Emergo in Austin, Texas. She has held positions in regulatory affairs for over 19 years at various medical device companies, most recently as a regulatory manager for Zimmer Orthobiologics.