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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.

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