Fact Sheets

How to determine legitimate FDA approval

Posted on by Congenius

Within the medical devices field, you may have come across terms like “FDA registered”, “FDA certified” and “FDA Registration Certificate”. Even if you see these terms accompanied by the FDA logo, they do not mean that the device is “FDA approved”, “FDA cleared” or “FDA authorised”.

Our latest fact sheet outlines the important differences between this terminology, providing a useful summary to help you determine whether a medical device is legitimately FDA approved. Access the resource by clicking on the Download button below.

Related News & Knowledge


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


    Subscribe to our
    monthly knowledge update

    Stay informed and up to date with the latest industry news delivered direct to your inbox. You can tailor your preferences to prioritise what you'd like to hear about each month; be it MedTech news headlines, fact sheet resources on the latest regulations or longer articles covering timely topics across the wider MedTech industry.