On June 16, 2016 the FDA officially released the much-anticipated Guidance Document Titled: Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” Guidance for Industry and Food and Drug Administration Staff. You can read the update here.
In response to the guidance release, NAMSA conducted an informational webinar on June 21st providing medical device manufacturers the first in-depth and interactive overview into this guidance. We highlighted important changes critical for manufacturers to know for their future medical device submissions. As a follow-up to that webinar, NAMSA is happy to host an expert panel discussion on the new guidance.
Manufacturer’s performing biological evaluations for future submissions need to employ strategies aligned to this guidance today, to ensure adherence during the submission process and we will answer your questions. With over 207 years of combined experience, specifically in Medical Device Biological Safety/Toxicology, NAMSA’s Biological Safety Team is prepared to answer those questions. We can also help manufacturers make the necessary updates to evaluation strategies after the FDA’s September 14th implementation date.