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FDA seeks comment on adverse event pilot project

Device Regulation Alert: Safety, Compliance and Reimbursement News, June 25, 2007

The FDA wants public commentary on continuation of a pilot project that evaluates adverse event reporting information concerning medical products. The project involves 400 facilities participating in the "Medical Device Safety Network (MedSun)."

The MedSun network not only collects adverse event information but also provides an opportunity for participants to share information with each other such as success stories about patient safety and quality improvement efforts.

Currently the universal reporting system for adverse events involving medical devices remains in effect. The FDA's June 13 notice seeking public comment explains that the pilot project was created in response to the FDA Modernization Act of 1997 which authorized replacement of the universal reporting system with one that is limited to a "representative sample" of user facilities.

The FDA is continuing the pilot project and seeks public comment by August 13 on various issues regarding data collection such as:

• Practical use of data collected
• Estimated burden of information collection
• Improvement of data quality
• Potential increase in automated data collection

To view the June 13, Federal Register click here and scroll to "Food and Drug Administration."

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