Final guidance from FDA on ISO 10993-1 and biological evaluation of medical devices

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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.

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm348890.pdf