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 Database

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.

FDA Guidance Documents

The FDA provides a searchable archive of official FDA Guidance Documents and other regulatory guidance.

Medical Device Databases

This lists and links to all of the relevant FDA databases regarding the regulation of Medical Devices.

Registration and Device Listing

This is a public listing of registered medical devices with the FDA.