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DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT OFFICE ADDRESS AND PHONE NUMERATE’S OF INSPECTION April 1822, 2016Food and DMG Administration 10903 New Hampshire Avenue,
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The Center for Devices and Radiological Health (CDRH) is responsible for regulating medical devices in the United States.
Manufacturers, distributors, and importers of medical devices are required to file with the Center for Devices and Radiological Health.
To fill out the Center for Devices and Radiological Health form, you must provide information about the medical device, its intended use, and any testing or clinical data.
The purpose of the Center for Devices and Radiological Health is to ensure the safety and effectiveness of medical devices sold in the United States.
Information such as the device classification, intended use, design specifications, manufacturing process, and labeling must be reported on the Center for Devices and Radiological Health form.
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