Articles on Law, Science, and Engineering

Medical Device Reporting: New Rules, New Concerns

By Edward P. Richards, 12 IEEE Engineering in Medicine and Biology Magazine #3, pg. 103 (September 1993)

This article reviews several new developments that affect the reporting of product-related injuries and product problems. Primary among these is the FDA's new emphasis on postmarket surveillance for drugs, devices, and biologicals. Secondary to the FDA's actions are changes in products liability law for medical devices and their potential effects on the liability of user facilities.[1] Manufacturers, distributors, and user facilities must review their medical device reporting (MDR) procedures to assure they meet the current legal requirements and best serve the entity's risk management goals.

INDEX

• The FDA and Medical Devices
• Postmarket Surveillance
• The MedWatch Program
• Problems with User Facility Reporting
• "Voluntary" Mandatory Reporting
• What Should You Report?