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”” 

Biocompatibility Assessment

The new resource pages are structured in 4 main levels.

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.

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