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.