Government Sites

Medical Devices, The European Commission, Europa. URL: http://europa.eu.int/comm/enterprise/medical_devices/. The Europa Web site is a central resource for European Union (EU) activities, regulations, statistics, and news about different industries. The medical device page provides links to the three European Directives that regulate the marketing of devices in EU countries—the Medical Devices Directive, Active Implan-table Medical Devices, and In Vitro Diagnostic Directive. Links are also provided to International Co-operation Treaties, such as the Global Harmonization Taskforce; Standards and Guidance documents, including Harmonized European Standards; and Competitiveness Facts and Figures. Information on meetings, seminars, and workshops are available (accessed October 2005).

U.S. Department of Commerce. International Trade Administration. Office of Microelectronics, Medical Equipment and Instrumentation. Washington DC, U.S.A. Phone: +1 202482-2470. E-mail: [email protected]. URL: http:// www.ita.doc.gov/td/health/regulations.html. Site for Medical Device Global Regulatory Requirements. Links to foreign regulations for medical equipment for nearly 40 countries.

U.S. FDA. 5600 Fishers Lane, Rockville MD 20857-0001, U.S.A. Phone: +1 888-INFO-FDA (+1 888-4636332). URL: http://www.fda.gov. A branch of the U.S. government's Department of Health and Human Services, the FDA is charged with regulating not only drugs, biologics and medical devices, but also food, animal feed and drugs, cosmetics, and radiation-emitting products, including cell phones and microwaves. The FDA Web site's sections for the CDRH and the OCP offer huge amounts of information on all aspects of the regulatory process. Industry assistance is available in the form of guidance documents; "Device Advice,'' which gives basic information about regulated products, how to classify a product, an explanation of 510(k)s, PMAs and IDEs, device labeling, exporting, and medical device reporting, third party inspections, and other topics. CDRH device program areas described include Human Factors, GMP, Postmarket surveillance, and

Reuse of single use products. Especially valuable are the searchable CDRH databases. These include Manufacturer and User Device Experience (MAUDE); PMA, Premarket Notifications [510(k)'s], and Device Listings, a list of medical devices in commercial distribution by both domestic and foreign manufacturers. The OCP site includes examples of newly approved combination products; guidance documents related to combination products; jurisdictional updates (among CDRH, CDER, and CBER); and instructions for submitting an RFD.

Global Harmonization Task Force (GHTF). Permanent Secretariat, Food and Drug Administration, Center for Devices and Radiologic Health, 1350 Piccard Drive, HFZ-220. Rock-ville, MD 20850, U.S.A. Phone: +1 301-443-6597, Fax: +1 301-443-8818. E-mail: [email protected]. URL: www.ghtf.org/ . The GHFT was formed in 1992 by a group of representatives from national regulatory authorities and the regulated industry, with the aim of achieving harmonization in medical device regulatory practices. The founding members were the European Union, the United States, Canada, and Japan, with Australia joining soon thereafter. Four study groups were established, each examining a different part of the regulatory process. In each case, the ultimate goal is to determine areas suitable for harmonization. The site provides links to various documents of the GHTF and its subcommittees; the status of various activities of the group; and working drafts, proposed documents, and final documents, as well as meeting summaries, of the subcommittees.

Medicines and Healthcare Products Regulatory Agency (MHRA). Market Towers, 1 Nine Elms Lane, London SW8 5NQ, U.K. Phone: +44-020-7084-2000, Fax: +44-020-70842353. E-mail: [email protected]. URL: http://www.mhra.gov.uk. The United Kingdom's (UK) equivalent agency to the U.S. FDA's device, pharmaceutics, and biologics centers. As such, MHRA is the regulatory authority for medical devices and pharmaceuticals; it regulates clinical trials, operates an adverse incident reporting system for devices, and issues safety warnings.

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