The FDA has classified over 1,700 distinct types of medical devices. The devices are organized in the Code of Federal Regulations (CFR) according to 16 specialties, such as Cardiovascular or Hematology devices. Classifying your medical device according to one of the 16 specialties is the first step to understanding whether you are manufacturing a Class I, II, or III medical device.
After classifying a device according to specialty, the FDA instructs manufacturers to proceed to premarket notification with knowledge of whether their device is exempt or not. Class I medical devices, the least risky and invasive category, are exempt from premarket notification processes. Specific class II devices are also exempt from premarket approval.
However, all devices regulated by the FDA are subject to current Good Manufacturing Practice (cGMP) requirements for registration, labeling, and quality. But how do you know if your device is Class I or II, and whether you’re required to undergo premarket notification?
Jinhua Huacheng Medical Appliance Co.,Ltd.
Manufactuer of disposable medical products: Electrosurgical pencil,grounding plate,skin stapler and ECG electrode
