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|CFR 21-801 - Labeling]] 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:
<<image /static/files/FDA/Example%20Class%20I.jpg width:600>>
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fda_public
created
Sat, 23 Jun 2012 18:17:18 GMT
creator
dirkjan
modified
Sat, 23 Jun 2012 18:17:18 GMT
modifier
dirkjan
tags
FDA
Term
creator
dirkjan