April Event: The FDA Medical Device Development Tool (MDDT) Program
The FDA Medical Device Development Tool (MDDT) Program: An Opportunity to Qualify Innovative Test Methods for Regulatory Use
Risk Science Consortium, LLC
Wednesday, April 21, 2021
Date: Wednesday, 21 April 2021
5:30 - 6:00 PM Virtual Networking
6:00 – 6:05 PM Welcome and Announcements
6:05 – 7:05 PM Program Presentation
7:05 – 7:30 PM Q & A *Times are approximate.
Biocompatibility testing of medical devices is undergoing an exciting evolution; transitioning from a process that largely relied on the results of animal testing to one that increasingly involves the use of New Approach Methods (NAMs), like in vitro methods and computational models, for the biological safety assessment of devices.
In this presentation, we will discuss the current regulatory environment regarding the acceptance of NAMs as part of a biological evaluation strategy for medical devices and we will explore how the FDA Medical Device Development Tool (MDDT) Program can be used as a means to qualify NAMs for regulatory use.
Ron will provide practical advice for developers of innovative new assays or software who may want to qualify their tools for regulatory use through the MDDT program and will also share some thoughts on how the increased regulatory acceptance of NAMs may shape the future of biocompatibility testing.
Ron Brown is a toxicologist with 35 years of experience in regulatory toxicology and risk assessment. He recently retired from the US FDA after 25 years of service and currently directs a small company, Risk Science Consortium, LLC, that provides consultation and training in toxicological risk assessment and computational toxicology.
At the FDA, Ron was the senior toxicologist responsible for developing and reviewing toxicological risk assessments of extractable and leachable (E&L) compounds from medical devices.
Prior to his position at the US FDA, Ron served as a Senior Associate at the ILSI Risk Science Institute. He is founding member and former President of the Medical Device and Combination Products Specialty Section of the Society of Toxicology and former President of the Dose-Response Specialty Section of the Society for Risk Analysis.
Not applicable - This is an online event
Online registration (ends 20Apr2021): $10 SDRAN Member
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