在不断变化的环境中掌握生物相容性测试.pdf

1、Sponsored byDanese Joiner-Fox,Ph.D.,StrykerHelin Rgel,Ph.D.,Nelson LaboratoriesSteph Street,Ph.D.,MedtronicEd Margerrison,Ph.D.,CDRH,U.S.FDAMastering Mastering Biocompatibility Biocompatibility Testing in a Shifting Testing in a Shifting LandscapeLandscapeMastering Biocompatibility Testing in a Shif

2、ting Landscape:Setting the Stage Industry Perspective Danese Joiner-FoxSenior Manager Regulatory AffairsStryker Sustainability Solutions Conducting Biocompatibility Assessments Can be Challenging Time MoneySample(Devices)Additional Challenges Addressing all recommended endpoints in the FDA biocompat

3、ibility guidance document Addressing the biocompatibility of instruments Sometimes the focus is on implants Inability to compare representative samples that are used for physical testing to the final finished deviceUse of International Standard ISO 10993-1,Biological evaluation of medical devices Pa

4、rt 1:Evaluation and testing within a risk management processAdditional Challenges Assessments that focus only on the biocompatibility of the material and fail to consider the effects of manufacturing,geometry,and sterilization Not having the submission numbers of utilized previously cleared or appro

5、ved devices Not having full test reports Strategies to use Chemical characterization to address all biocompatibility endpoints Not accepted for sensitization,irritation and material mediated pyrogenicityBest Practices Best Practices Balance providing the necessary information for review Providing ex

6、traneous or unnecessary information may confuse a reviewer and potentially cause delays Address all recommended biocompatibility endpoints per the FDA guidance document Provide complete test reports Fully describe testing conditions,deviations,results,and conclusionsBest Practices Best Practices Whe