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see also: Feature

Reporting Adverse Effects

Although manufacturers perform device testing and clinical trials to identify potential failures, risk to patients, or user error, it is impossible to foresee all potential adverse events that could occur once a device is in commercial distribution and in use within the medical community. Therefore, it is important for both manufacturers and the FDA to be informed of adverse events and user errors that cause potential or real injury to either the patient or the medical professional using the device. Visit the FDA Web page at http://www.fda.gov/medwatch to access the MedWatch online device reporting system for health care professionals.

Resources

• Check the FDA CDRH Web site at http://www.fda.gov/cdrh/ to learn about new drugs and devices that have been approved for marketing. For approved devices, a "Summary of Safety and Effectiveness" is available
• MedWatch device reporting program is available at http://www.fda.gov/medwatch
• Information about the FDA Modernization Act of 1997 is available at http://www.fda.gov/cdrh/modact/modern.html