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How We Can HelpThe 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:
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.
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Updated July 27, 2006
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