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Resources: Sources of Information: Government


FDA Food and Drug Administration. FDA has the responsibility regulates marketed medical products including drugs, biologics, medical and radiation-emitting devices, and special nutritional products (e.g., medical foods, dietary supplements and infant formulas). The site has a wealth of information about device safety and incident reports, as well as periodic bulletins on medical devices and drugs.
MedWatch, the FDA Medical Products Reporting Program FDA Medical Products Reporting Program. Designed to educate all health professionals about reporting and being aware of adverse events and problems to FDA and/or the manufacturer, as well as a communication vehicle to rapidly deploy critical safety information to the medical community that may improve patient care.
Center for Devices and Radiological Health (CDRH) Premier spot at FDA for regulatory information about medical devices.
Center for Devices and Radiological Health (CDRH) - Medical Device Reports Device experience reports (over 600,000) on devices that may have malfunctioned or caused a serious injury or death. The reports include both reports submitted to the (mandatory) Medical Device Reporting Program (MDR), from 1984-1996, and voluntary reports through June 1993. Reports from 1992 to 1996 can be searched online at this page. Also links to organizations that provide more up-to-date Device Experience Network (DEN) information, for a fee.
Federal Register Searchable Federal Register (from 1994) that includes announcements and publications from FDA.
The Code of Federal Regulations Searchable database that includes, of course, FDA regulations
ISO Easy Information about the ISO 9000 and 9001 standards for quality assurance.
Center for Drug Evaluation and Research Section of the FDA that monitors pharmaceuticals and research.
FDA Drug Approval List Drugs approved by the FDA (since July, 1996). List is updated weekly.
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