Classifying your medical device according to one of the 16 specialties is the first step to understanding whether you are manufacturing Class I, II, or III medical devices. The devices are organized in the Code of Federal Regulations (CFR) according to 16 specialties, such as cardiovascular or hematology devices. The FDA has classified over 1,700 distinct types of medical devices. With this knowledge, medical device manufacturers in the premarket stages can better prepare and allocate the resources needed for regulatory approval.Äownload medical device classification PDF guideÄifferences between FDA Medical Device Classes Before you begin creating a medical device, you need to know what class it falls under so you can follow the correct procedures and regulations set by the U.S. Class I devices are subject to far fewer regulatory requirements than Class II or III devices. There is an enormous difference in the optimal path to market for manufacturers depending on how your device is grouped. The FDA medical device classification guidelines can be highly confusing to medical device manufacturers who may have limited exposure to the system. But where are the lines drawn between each of these three classes, and why? Any medical device approved by the FDA Center for Devices and Radiological Health is classified as either Class I, II, or III depending on the new device's risk, invasiveness, and impact on the patient's overall health. , which are grouped into three broad classes. The FDA regulates all medical devices marketed in the U.S.
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