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.
FDA submission requirements
- If your product falls under the Class I category, you most likely do not have to obtain FDA approval or clearance. However, you must still meet Class I FDA product registration requirements.
- If your product falls under the Class II category, you will most likely need to make a 510(k) submission in order to satisfy FDA device registration requirements. Your FDA 510(k) filing may or may not have to include clinical data depending on the nature of your device.
- If your product is a Class III device, your FDA submission consists of a Pre-Sub (Pre-IDE) and IDE consulting.
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.