Medical Equipment Safety

Medical Equipment Safety

Medical Equipment Safety

Medical Equipment Safety

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Industry Specific
Each year the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries, and malfunctions. Medical Device Reporting (MDR) is one of the surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. In this course, you will review the Food and Drug Administration’s (FDA) consensus standards for domestic and international medical devices, their role in medical device safety, and the FDA Modernization Act of 1997. Additionally, the course reviews basic regulatory requirements including device registration and listing requirements, premarket notification, investigational device exemptions for clinical studies, the quality system, and labeling requirements. The final chapter of the course covers the expansion of the FDA's authority to promote innovation, increase stakeholder activity, and enhance the safety of the drug supply chain.

COURSE INFORMATION

N/A 30 minValid for 12 monthsCreated 2018-07-18Updated 2020-10-28

Course Objectives

  • Discuss the Food and Drug Administration’s role in medical device safety, the FDA Modernization Act of 1997
  • Focus on the greatest risks and benefits of medical devices
  • Discuss registration, medical device listing requirements, premarket notification, investigational device exemptions for clinical studies, the quality system, and labeling requirements

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