Originally Published MDDI
November 2003
REGULATORY OUTLOOK
FDA Guidance Documents Referencing Risk ManagementHarvey Rudolph
Underwriters Laboratories Inc.
• Contents of a Product Development Protocol
• Guidance on QSR Information for Various Premarket Submissions
• Medical Device Use Safety: Incorporating Human Factors Engineering
into Risk Management
• Premarket Submissions for Software Contained in Medical Devices
• Off-the-Shelf Software Used in Medical Devices
• General Principles of Software Validation
• Class II Special Controls Guidance for Home Uterine Activity Monitors
• Electro-Optical Sensors for the In Vivo Detection of Cervical Cancer
Copyright ©2003 Medical Device & Diagnostic Industry
