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FDA Medical Products Reporting Program


The FDA established this website in order to educate healthcare professionals about the importance of monitoring for, and reporting on, any adverse effects of medical products. The FDA outlined four main goals for the program: (1) To increase awareness of diseases induced by drugs or medical devices; (2) To clarify what should be reported to the FDA; (3) To provide information to the healthcare community about the safety issues concerning medical products, and (4) To make it easier to report adverse effects of drugs to the FDA. With these four aims in place, the FDA hopes that any significant health hazards can be quickly identified and thus improve the standard of patient care.


The site provides the means to submit reports via the Internet through ready-provided forms which differ according to whether a consumer, a healthcare profesional or a veterinarian is submitting the report. There is also a section covering safety information which includes lists of drug labelling changes, recalls and market withdrawals of plasma products, drug and food interactions, adverse effects associated with the use of nutrional products and information on medical devices that may have malfunctioned or caused injury. MedWatch also provides continuing education articles and FDA medical bulletins.


The MedWatch site contains very comprehensive and detailed information about drug safety and is certain to be of value to all healthcare professionals. In addition, MedWatch offers immediate notification via email, of any new material as soon as it is posted on to the site.

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Waterworth, C. FDA Medical Products Reporting Program . Crit Care 4, webreport1663 (2000).

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  • Healthcare Professional
  • Medical Device
  • Safety Issue
  • Medical Product
  • Health Hazard