Class I Medical Device and General Controls:
Consisting of simplistic designs and being generally safe to use, medical devices belonging to Class I tend to be simpler than the devices in Class II and III. Due to their simplicity, these devices are required to adhere to just the general controls under the Quality System of FDA. These general controls include apt labelling and branding, the mechanism of general reporting, manufacturing techniques that follow protocols, FDA notification prior to the product’s marketing as well as registration of the company manufacturing the product with FDA. a majority of the devices falling in the class I category are required to adhere merely to the good practices of manufacture or the notification to the FDA clause as these are thought to be sufficient enough to ensure that the device is safe and effective since this kind of devices normally do not pose any sort of danger by their use in normal life and are not in the list of life supporting devices.
Manufacturing Cost effective Class I Devices:
Some of the devices that fall in the Class I category are common equipment like bandages, surgical instruments that are handheld, gloves used in medical examination, tongue depressors and bedpans. Such devices might need to acquire a 510(K) Pre Market Notification, the requirement depends on what is the purpose that the device is stated to fulfill. The arthroscope that runs on electric power is one such device, It requires a 510(K) and devices of this kind are called “reserved”.