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Medical Devices

NAMs for Medical Devices


Description

Welcome to the NURA course NAMs for Medical Devices: Use of New Approach Methodologies for the Biological Safety Assessment of Medical Devices


During this two-day webinar, a diverse group of experts from industry, government, and advocacy sectors gathered to discuss the state of the science for NAMs within the context of medical device development and testing.


Speakers:

Jessica Ponder, PhD, (formerly) Physicians Committee for Responsible Medicine

Jennifer Goode, BS, Office of Product Evaluation and Quality (OPEQ), US FDA-CDRH

Rose-Marie Jenvert, PhD, SenzaGen

Jeffrey Brown, MPH, PETA Science Consortium International

Erin Hill, Institute for In Vitro Sciences

Kristie Sullivan, MPH, (formerly) Physicians Committee for Responsible Medicine

Ron Brown, Risk Science Consortium, LLC

Andrew D. Nguyen, PhD, PETA Science Consortium International

Michael F. Wolf, MS, Medtronic

Megan Jamiolkowski, PhD, Office of Science and Engineering Laboratories (OSEL), US FDA-CDRH


This course was recorded in December 2021. Credentials and affiliations for speakers and presenters may have changed since the recording.


The videos in this course are available with English and Spanish subtitles. To access these, select the "Settings" (gear) icon within the video.

Content
  • Introduction
  • 1.1 Introduction to Session 1 of NAMs for Medical Devices
  • 1.2 Keynote: Medical Device Development Tools Program
  • 1.3 In Vitro Irritation Testing: Validation, Follow-Up, & Regulatory Acceptance
  • 1.4 In Vitro Skin Sensitization: ISO 10993-20 Validation & Regulatory Acceptance
  • 1.5 In Vitro Vaginal Irritation Testing of Personal Lubricants: MDDT Case Study
  • 1.6 Session 1 Panel Discussion
  • 2.1 Introduction to Session 2 of NAMs for Medical Devices
  • 2.2 Chemical Characterization for Risk Assessment
  • 2.3 Monocyte Activation Test: Viable Nonanimal Pyrogen Test for Medical Devices
  • 2.4 NAMs for Assessment of Human Blood Interactions of Medical Devices
  • 2.5 In Vitro Dynamic Thrombogenicity Testing of Biomaterials
  • 2.6 Session 2 Panel Discussion
  • Course Survey, Medical Devices
Completion rules
  • All units must be completed
  • Leads to a certificate with a duration: Forever
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