FDA Guidance Documents Referencing Risk Management

Originally Published MDDI November 2003

REGULATORY OUTLOOK

Harvey 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   

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