What's New

A guide to 513(g) requests with the FDA

Posted on by Congenius

A 513(g) request for information is a means for medical device manufacturers to obtain information about the FDA’s views regarding the classification and regulatory requirements for a particular product.

Our fact sheet below covers what a 513(g) request for information can be used for, what needs to be included in your request, and what to expect in response from the FDA. Access this short and easy to read resource by clicking on the Download button below.


Get in touch

If you have a challenge that you think we could help with, please feel free to get in touch by filling out our contact form or by giving us a call. We look forward to speaking with you!

Congenius AG
Riedstrasse 1
CH-8953 Dietikon

e: info@congenius.ch
t: +41 44 741 04 04