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Device advice | CDRH`s self-service site for medical device and radiation emitting product information. Device Advice is an interactive system obtaining information concerning medical devices |
Guidance documents | Documents prepared for CDRH staff, regulated industry and the public that relate to the processing, content, and evaluation of regulatory submissions; the design, production, manufacturing, and testing of regulated products; and inspection and enforcement procedures |
Industry support | Technical and regulatory assistance to small manufacturers to help them comply with FDA's requirements for medical devices. |
International issues | Activities involving the import and export of medical devices and international harmonization in the regulation of medical devices |
Medical device reporting (MDR) | Process by which industry, importers, user facilities, and the public can inform the FDA of problems with medical devices |
Obtaining market clearance / approval | Steps involved in getting a medical device to market including marketing, proper labeling and monitoring its performance once the device is on the market |
Ombudsman | Investigates complaints from outside FDA, and facilitates the resolution of disputes between CDRH and the industry it regulates |
Standards | Practices recognized by CDRH that can be used by Industry as part of the process of determining the "safety and effectiveness" of new medical devices |
Third party review | Process allowing 510(k) submitters to use FDA-accredited third party review organizations ("Accredited Persons") in place of FDA's review for certain medical devices |
Updated 9/30/2002
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Center for Devices and Radiological Health / CDRH