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• What We Do
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What We Do

The Center for Devices and Radiological Health (CDRH) is responsible for regulating medical devices and radiation-emitting products. For an overview of CDRH, please see our brochure entitled, "Center for Devices and Radiological Health; Promoting and Protecting Public Health."

The Consumer Staff of CDRH within the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) responds to general consumer inquiries on medical devices and radiation-emitting products.

It is sometimes difficult to know if a product is a medical device and whether it is regulated by CDRH, another Center within FDA or possibly another federal agency. Below are examples of the various products that get mistaken for medical devices and areas of oversight incorrectly thought to belong to FDA:

• Norplant, weight loss drugs, sunscreens, oxygen and dyes used in conjunction with x-rays are considered to be drugs and questions should be directed to the Center for Drug Evaluation and Research (CDER).
• HIV tests and hepatitis tests used in donor screening are reviewed by FDA’s Center for Biologics and Research (CBER).
• Food safety, dietary supplements (including vitamins), and cosmetics are regulated by FDA’s Center for Food Safety and Applied Nutrition (CFSAN).
• Infant diapers, general exercise equipment, air purifiers, and sun protective clothing are consumer products and questions should be directed to the Consumer Product Safety Commission (CPSC). There are circumstances when FDA does regulate sun protective clothing. See correspondence previously issued by CDRH for more information on this topic.
• Power line inquiries should be directed to the Environmental Protection Agency (EPA).
• Reimbursement of medical devices is handled by the Centers for Medicare and Medicaid Services (CMS).

How to Contact Us

When corresponding or requesting information from the CDRH Consumer Staff, please include your telephone and FAX numbers, mailing/E-mail address in your request. We encourage your comments or suggestions on our website.