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[FDA News] Webinar on September 12 - Qualification of Medical Device Development Tools

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.

Provision work professionally while meeting clients' needs.

We will streamline the regulatory processes

so that our clients can utilize their time

and money most efficiently.

Experience the best FDA approval directions and solutions!

If you have questions about FDA regulation of Medical Devicese,

OTC Drugs, Cosmetic or importing of medical devices to the United States,


Office 1-909-493-3276


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