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Industry Assistance

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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