Course Description

This web seminar provides an overview of the regulations and obligations of a sponsor and investigator in the development of a new device using FDA and ICH guidance — Investigational Device Exemption (IDE) and abbreviated IDE processes. This is done by reviewing sponsor and investigator obligations, along with the principles of Good Clinical Practice (GCP). Definitions used by sponsors and regulatory authorities for device development will be reviewed. Participants will become familiar with the regulatory decision-making process used by the FDA and learn to navigate the approval pathways to market.

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Learning Objectives

• Discuss the FDA regulations and practical application of sponsor and investigator obligations defined in 21CFR812
• Describe the structure, purpose, and practical application of the ICH Guideline and its principles of GCP
• Describe the technical standards defined in ISO
• Define common terms used in device research
• Describe the three decisions in device development (classification, equivalence, and risk)
• Define the two pathways to market (PMA and 510(k))
• Navigate the FDA approval process
• Describe what an IDE and PMA are, identify their contents, and discuss the FDA review process

Who Should Attend

• Clinical Research Managers
• Principal Investigators
• Regulatory Associates
• Quality Assurance Personnel
• All other personnel responsible for the device approval process

Instructor

Gary B. Freeman, M.S.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.