Fact Sheets

3 steps to Classifying Medical Devices in the US

Posted on by Congenius

The process of classifying a medical device in the US involves reviewing the potential regulatory class (I, II or III), finding the classification of your device as well as any exemptions that may exist, and potentially submitting a 513(g) request.

Download our fact sheet below to learn more about the three steps to take when looking to classify your medical device in the US. And if you’re looking for information on classifying your medical device in the EU, click here.

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