FDA Compliance - Techlink

FDA 513(g) Consulting for Medical Devices

It is not uncommon for the classification of a Medical Device to be unclear

There are times when some types of medical devices can be difficult to classify for various reasons. An option for obtaining written advice about the classification is a 513(g) request. submitted to the FDA. In order to obtain confirmation or determine the right classification for your medical device, TechLink International submits on your behalf a 513 (g) document to the FDA mentioning the features and reasons for selecting a particular category.

Within 60 days of such a request the FDA shall provide a written statement which will confirm the classification.

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