- September 12, 2023
- 1:00 PM - 2:15 PM ET
On September 12, 2023, the U.S. Food and Drug Administration (FDA) held a webinar for industry and other interested stakeholders to discuss the Medical Device Development Tools program, and the associated final guidance: Qualification of Medical Device Development Tools.
During the webinar, the FDA:
- Defined medical device development tools (MDDTs)
- Discussed MDDT qualification and its benefits
- Described the qualification decision framework
- Discussed other regulatory considerations and related recommendations
- Discussed how to submit an MDDT submission package
- Discussed the procedural updates made to the MDDT program, as reflected in the recently updated final guidance.
- Answered questions about the MDDT program.
The purpose of this webinar was to describe the Medical Device Development Tools Program, which is intended to facilitate device development, timely evaluation of medical devices, and promote innovation by providing a more efficient and predictable means for collecting the necessary information to support regulatory submissions and associated decision-making.
The presentation, printable slides, and transcript are available on CDRH Learn under “Specialty Technical Topics,” sub-section “Regulatory Science Tools.”
If you have questions about this guidance document, please contact CDRH’s Medical Device Development Tools Program at MDDT@fda.hhs.gov. If you have questions about this webinar, please contact CDRH's Division of Industry and Consumer Education (DICE) at firstname.lastname@example.org, 1-800-638-2041, or 301-796-7100.