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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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