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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. |
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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. |
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Center
for Devices and Radiological Health (CDRH) |
Premier spot at FDA for regulatory information
about medical devices. |
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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. |
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Federal
Register |
Searchable Federal Register (from 1994)
that includes announcements and publications from FDA. |
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The
Code of Federal Regulations |
Searchable database that includes, of
course, FDA regulations |
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ISO
Easy |
Information about the ISO 9000 and 9001
standards for quality assurance. |
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Center
for Drug Evaluation and Research |
Section of the FDA that monitors pharmaceuticals
and research. |
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FDA
Drug Approval List |
Drugs approved by the FDA (since July,
1996). List is updated weekly. |
