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FDA
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Within FDA, the Center for Devices and Radiological Health (CDRH) develops and implements national programs to protect the public health in the fields of medical devices and radiological health. These programs are intended to assure the safety, effectiveness, and proper labeling of medical devices; to promote quality in mammographic services; and to control unnecessary human exposure to potentially hazardous radiation and ensure the safe, efficacious use of such radiation. The Center reviews and evaluates medical device premarket approval (PMA) applications, exemption requests for investigational devices (IDEs), and premarket notifications [510(k)s]. CDRH also develops and enforces performance standards for medical devices and radiation-emitting electronic products and GMP regulations.
Under the Safe Medical Devices Act of 1990, CDRH has established an International Staff to coordinate the development of agreements with foreign countries in order to facilitate trade in devices. Additional information about medical device international activities is available on its International Program page.
Contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) for assistance:
Contact the Office of Compliance:
Contact DSMICA/International Staff:
Many documents concerning FDA-regulated medical devices and radiation-emitting electronic products are available on the FDA Home Page, in the CDRH section. You can obtain information on how to export, import, or market devices in the United States.
Notice of Status for Premarket Notification [510(k)] Submission - This provides manufacturers FAXed information on the status of their submissions: 90 days after submission, request status by dialing (240) 276-3150 and following the instructions.
Publications - Regulation of Medical Devices: Background Information for Foreign Officials is a comprehensive document, prepared by CDRH International Staff, that explains how FDA is organized and how CDRH approaches its mandate to protect the public health in the field of medical devices.
Publications can be requested from DSMA at (240) 276-3150 or FAX: (240) 276-3151.