Dirkjan: Created page with "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 genera..."

2020-08-25T07:19:06Z

Created page with "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 genera..."

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Class I Medical Devices are subject only to the FDA's [[General Controls|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|Good Manufacturing Practices]]
# Label medical devices in accordance with the labeling regulations, [[CFR 21-801 - Labeling|21 CFR 801]] or [[21 CFR 809|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:

<html><img src = "/static/files/FDA/Example%20Class%20I.jpg" width="600"/></html>

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[[Category:FDA]]

[[Category:Term]]

Class I Medical Devices - Revision history

Dirkjan: Created page with "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 genera..."