FDA’s New ISO 10993-1 Biocompatibility Evaluation Guidance

On June 16th, 20016, FDA published a final guidance on biocompatibility evaluation called, Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.

Special consideration should be paid to Attachment A of the guidance document which provides a framework for the development of a biocompatibility testing plan. FDA claims Attachment A is not a “checklist” for testing, but rather a checklist of considerations that need to be made when thinking about the biocompatibility of a device in its final finished form (FFF). FDA’s expectation is that all submissions to the FDA address all of the “Xs and Os” on in the biocompatibility safety evaluation (Attachment A). Information such as existing data, additional endpoint-specific testing, or rationales can be used. If testing is performed, the guidance document includes additional information on endpoint considerations for the following: cytotoxicity, sensitization, hemocompatibility, pyrogenicity, implantation, genotoxicity, carcinogenicity, reproductive & development toxicity, and degradation assessments. New materials used in a device might require additional evaluations beyond those mentioned in Attachment A, and devices with multiple types of exposure should include information to address each exposure category. It is critical to understand this guidance when commercializing a medical device.

To read the guidance, click the link here: http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm348890.pdf
FDA also published a webinar which can be found here:
http://www.fda.gov/medicaldevices/newsevents/workshopsconferences/ucm507235.htm

Posted by Spencer Kimber