Class I Medical Devices
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Class I Medical Devices are subject only to the FDA's General Controls because they are the least complicated and present the least risk. The FDA's general controls are though to provide reasonable asurance of the safe and effective use of these devices:
- Register manufacturing and distribution locations
- List device to be marketed with FDA
- Manufacture the devices in accordance with Good Manufacturing Practices
- Label medical devices in accordance with the labeling regulations, 21 CFR 801 or 21 CFR 809
- Report adverse events of medical device as identified by the user, manufacturer and/or distributor
Examples
Examples of Class I devices include tongue depressors, arm slings, and stethoscopes:
