In April of 2016, the FDA released their long-awaited guidance document on ISO 10993. This 65 page document provides insights and changes to how the FDA views biocompatibility. We will discuss the top 10 items in the document that will make the greatest impact; we will also discuss how this update impacts the newest draft of ISO 10993-1.
Attendees will expect to learn:
- The most current FDA trends regarding biocompatibility
- How to add risk management into biocompatibility
- How material/chemical characterization plays a role in biocompatibility
- What’s on the horizon for change in biocompatibility