Title: Class I Medical Devices
Course: BTEC-1300-301-302-303-F21 > Section: Regulations and Medical Devices

Class I medical devices have almost no potential risk and are subject to the least amount of regulatory control. Medical devices in this category are unlikely to result in serious consequences when the device fails or is misused.

Manufacturers of Class I medical devices adhere to "General Controls".

The FDA requires general controls of all medical device manufacturers. Medical devices that fall under this classification are not intended to help support or sustain life or are not substantially important in preventing impairment to human health. Additionally, they don’t present unreasonable risk of illness or injury. Class I medical devices can generally be sold without pre approval by the FDA.

Examples of Class I medical devices:

- bandage
- glove
- scalpel
- stethoscope
- tongue depressor
- breast pump

Learning Objectives:

- 1.1 - Describe the role of the FDA and other regulatory bodies in the manufacturing of medical devices.