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  4. How can I find out if my product is regulated by CDRH?
  1. FDA Basics for Industry

How can I find out if my product is regulated by CDRH?

The U.S. Food and Drug Administration (FDA) regulates medical devices to assure their safety and effectiveness. The Center for Devices and Radiological Health (CDRH) is the component within the FDA that is responsible for this implementing this regulation. The FDA's legal authority to regulate medical devices is the Federal Food Drug & Cosmetic (FD&C) Act.

For more information, please visit the Device Advice website.