How to determine legitimate FDA approval

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Congenius

Fact Sheets

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.

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