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US Regulatory Resources
Regulatory requirements in the United States are subject to revision and change. Below you will find maintained, up-to-date regulatory guidance to ensure that your path starts and follows a positive course.
FDA 21 CFR is the comprehensive Code of Federal Regulations for the regulation of medical devices. This site is a searchable database for regulatory requirements in the United States.
The FDA provides a searchable archive of official FDA Guidance Documents and other regulatory guidance.
This lists and links to all of the relevant FDA databases regarding the regulation of Medical Devices.
This is a public listing of registered medical devices with the FDA.
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