Final guidance from FDA on ISO 10993-1 and biological evaluation of medical devices
FDA has published a final guidance on the biological evaluation of sterile and non-sterile medical devices that come into direct or indirect contact with the human body. The document specifically covers the use of ISO 10993-1 but also relevant to other biocompatibility standards ( other parties of ISO 10993; USP; ASTM; ICH)
FDA guidance on ISO 10993-1 has not been updated since 1995. The novelty of final version is that manufacturers should perform a risk assessment in order to evaluate if the biocompatibility testing is needed.
The guidance document also provides details regarding the chemical assessment and biocompatibility test for devices using nanotechnology.