The U.S. Food and Drug Administration (FDA) is scheduled to hold a webinar on September 12, 2023. This webinar is intended for industry professionals and other interested parties to engage in discussions regarding the Medical Device Development Tools (MDDTs) program and the accompanying final guidance document titled "Qualification of Medical Device Development Tools."
This webinar aims to facilitate medical device development by explaining MDDTs and ensuring timely evaluation of medical devices. Additionally, it aims to provide a role in promoting the efficient and predictable collection of information necessary to support regulatory submissions and associated decision-making for medical devices.
Topics to be Covered
Define medical device development tools (MDDTs)
Discuss MDDT qualification and its benefits
Describe the qualification decision framework
Discuss other regulatory considerations and related recommendations
Discuss how to submit an MDDT submission package
Discuss the procedural updates made to the MDDT program, as reflected in the recently updated final guidance.
Answer questions about the MDDT program.
Date and Time
September 12, 2023, 1:00 PM – 2:15 PM (Eastern Time)
Please refer to the following for participation instructions.
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