FDA issued a new page called “Biocompatibility Assessment Resource Center”, where you can find useful information for your biocompatibility evaluation. The web pages mainly include explanation of terms and concepts important for a biocompatibility evaluation of a medical devices.
As you might already know, the general principals are already specified in the guidance document “Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process””
The new resource pages are structured in 4 main levels.
- Step 1 Biocompatibility Basics
- Step 2 Biocompatibility Evaluation Endpoints (Device Category and Contact Duration)
- Step 3 Documenting How a Test Article Compares to the Proposed Medical Device
- Step 4 Content of Test Reports
The page called “Component and Device Documentation Examples for Test Articles or Previously Marketed Devices” (3rd Step) includes especially useful guidance on Component documentation, Device documentation, New processing/sterilization changes and Formulation changes. The information given on these pages can be used in preparation of a 510 K Submission. It is also possible that manufacturers use this information as a state-of-the-art guidance during preparation of technical documentation for MDR (EU 2017/745) and related clinical evaluation.