FDA Center for Devices & Radiological Health Presents: Understanding Risk with Medical Devices Public Virtual Workshop
The U.S. Food and Drug Administration (FDA) is announcing a virtual public workshop Understanding Risk with Medical Devices. This 2-hour workshop will expand on the basics of risk associated with medical device use by featuring Risk Basics for Medical Devices and Application of Risk Management Principles for Medical Devices. The presentations will be followed by a live question-and-answer session with stakeholders and a panel of CDRH leaders.
Workshop Summaries
Risk Basics for Medical Devices (Joseph Tartal, Deputy Director Division of Industry and Consumer Education)
Understanding risk is a necessity to bring and keep a medical device on the market. These basic concepts will start you on the journey to determine the risk of your medical device, which will increase predictability, aid in appropriate design and manufacturing, and provide clearer premarket submission regulatory expectations. This session will discuss the basics of risk and use a generic example to help establish a fundamental understanding of risk.
Application of Risk Management Principles for Medical Devices (Tonya Wilbon, Branch Chief, Postmarket and Consumer Branch, Division of Industry and Consumer Education)
Medical device manufacturers are required to make risk-based decisions and conduct risk management activities as a part of the design, manufacture, and production of medical devices or in general as part of the quality system. In addition, the regulation of medical devices incorporates risk-based decisions to assure devices are safe and effective. This session will provide an understanding of the application of risk management principles and review of risk information for medical devices.
Each session will include a presentation, followed by a moderated live question-and-answer session with a panel of CDRH leaders. Audience participants are encouraged to email or call with questions during each session.
Participants may choose one or both sessions. Each session will begin at the scheduled time.
- 1:00 - 2:00 PM ET: Risk Basics for Medical Devices
- 2:00 - 3:00 PM ET: Application of Risk Management Principles for Medical Devices