Preparing a FDA 513(g) Submission to Obtain a Classification Ruling
We can generally classify most medical devices very easily based on experience. However, there are situations where a new medical device may be difficult to classify. For example, devices that have been classified as 510(k) exempt by the FDA but possess new technology or are marketed for a different intended use than the classified device, should have their classification and route to compliance verified by the FDA.
In these cases, we can submit a 513(g) document to the FDA on your behalf seeking a classification confirmation, or unusual circumstances, a classification determination. We can prepare and submit a 513(g) document to the FDA outlining the characteristics of the device and our rationale for why it should fall into a specific class. The FDA will then render a decision on how the device should be classified.
