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Whats The Difference Between A Class I And Class II Medical Device?

1. What is Considered a Class I Medical Device?

Class, I medical devices are subject to the FDA’s general controls and “are sufficient to provide reasonable assurance of the safety and effectiveness of the device.” Class, I devices have a low impact on patients’ overall health and do not come into contact with their organs, the central nervous system, or the cardiovascular system. 

These devices are subject to the fewest regulatory requirements. If you want to know more about clinical devices, then you can read the clinical course curriculum to join online medical courses. 

General controls include:

  • Adulteration

  • Misbranding

  • Device registration and listing

  • Premarket notification (510(k)) (for a limited number of class I devices)

  • Notification and repair, replacement, or refund

  • Records and reports

  • Banned devices

  • Good manufacturing practices (unless exempt)

Examples of class I medical devices include elastic bandages, examination gloves, electric toothbrushes, hospital beds, and hand-held surgical instruments, to name a few.

2. What is a Class II Medical Device?

The main difference between a class I and a Class II medical device is its risk level. Class II devices are intermediate-risk devices for which general controls are not sufficient to ensure safety and effectiveness. These devices must meet general controls as well as special controls, if applicable, which include:

  • Performance standards

  • Post-market surveillance

  • Patient registries

  • Guidances and guidelines

  • And other appropriate actions

A class II medical device, simply put, is a device that poses a greater risk to patients than a class I. One of the most notable differences between a class I and class II medical device is the issue of premarket notification.