Скачать или смотреть FDA-NIH 2024 | D1S15 - CDRH Medical Device Development Tools (MDDT) Program

This presentation provided an overview of CDRH's Medical Device Development Tools (MDDT) Program and explained what constitutes an MDDT. The session outlined the MDDT submission process and described how MDDTs integrate with regulatory review procedures. Key aspects of the program were discussed to help stakeholders understand how to effectively utilize MDDTs in medical device development and regulatory submissions.

Timestamps

00:43 – The Medical Device Development Tools (MDDT) Program

03:51 – What is an MDDT

05:47 – MDDT Submission Process

10:57 – Qualified MDDTs

12:18 – Summary

Speaker:

Jessica Mavadia-Shukla, PhD
Director | Medical Device Development Tools Program
Division of Partnerships and Innovation (DPI)
Office of Equity and Innovative Development (OEID)
Office of Strategic Partnerships and Technology Innovation (OST) | CDRH

Learn more at: https://www.fda.gov/drugs/news-events...

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