Webinar: Time for a Change: Evidence-Based Approaches for the Biological Safety Assessment of Medical Devices
Join this free webinar where Ron Brown, toxicologist and former FDA risk assessor, will outline the need for a new and more agile approach for the biological safety assessment of medical devices.
This presentation will identify the limitations associated with the current approach, which largely relies on animal-based tests that may have questionable clinical relevance. It will also describe how new and existing biocompatibility test methods can be evaluated following the principles of an evidence-based toxicology (EBT).
You will also learn how to incorporate New Approach Methodologies (NAMs) into a streamlined workflow for the safety assessment of medical devices, which may decrease the time needed for regulatory approval of a device.
Key takeaways
- The limitations associated with animal-based approaches used to assess the biological safety of medical devices.
- How to assess the validity of NAMs by using an evidence-based toxicology (EBT) approach.
- How to incorporate NAMs into a streamlined workflow for medical device safety assessment.
- A case study on the OECD approval of the in vitro assay GARDskin and its applicability for Medical Device assessments supporting both polar and non-polar extraction vehicles (ISO 10993-12).
Speakers
Ron Brown, Toxicologist at Risk Science Consortium (former FDA scientist)
Andy Forreryd, PhD, Scientific Liaison, SenzaGen