FDA's Medical Device Software Regulation Strategy

"Understanding FDA legal authority"
The growth of the medical software industry outpaces the design of FDA's regulatory process. In some instances clinicians have weighed the risk of software failure against the benefits of using a device at all. Device software is often used in conjunction with other software-based devices, but their interoperability was never anticipated.This seminar will help those involved in overcoming these commercial and regulatory obstacles. It will highlight the need for firms to remain current with technological tools and strategy to remain competitive, and ideally, outside FDA’s regulatory radar.

Highlights

• Office of the National Coordinator (ONC) for Health Information Protection,Types of Software Devices
• National Institute of Science and Technology Report,Device Vulnerabilities: Malfunction and Failure
• National Institute of Science and Technology Report and Collaboration,FDA Regulatory Strategy
• Criteria for corrective and preventive action deemed recalls,FDA Regulation of Accessories
• Federal Communications Commission (FCC) Regulation,Labeling: Instructions for Use and Precautions