Commercializing your medical device or IVD in the US market requires submitting registration applications to the US Food and Drug Administration (FDA). The content of your FDA submission depends largely on how your medical device or IVD is classified according to the agency’s classification scheme. Class I, Class II and Class III categories can entail different FDA registration requirements for medical devices. Here is a brief overview.
In instances where a medical device is difficult to classify due to new technology and intended use, Emergo can conduct a formal classification request known as a 513(g) submission to the FDA on your behalf. Once the FDA confirms or determines the classification of your device, we can proceed with your FDA submission. For a detailed look at the approval process, download our free FDA regulatory chart.