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U.S. Department of Health and Human Services

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Laboratory of Solid Mechanics

Lab Leader: Terry Woods 301-796-2503 Terry.Woods@fda.hhs.gov

The goal of the DSFM Solid Mechanics Laboratory is to help CDRH understand the response of medical devices and their constituent materials to applied stress for both pre-market evaluations and post-market reported adverse events. The materials of interest include traditional engineering materials such as metals and polymers, but also extend to biological materials and those used in tissue engineered scaffolds. Though the spectrum of relevant materials is broad, common stress analysis principles can be applied to evaluate their behavior. We have the capabilities to measure mechanical properties ranging from the tensile strength of sutures and medical glove materials, to the fatigue strength of total joint prostheses and cardiovascular stents. Our measurement capabilities go beyond purely mechanical characterizations. For instance, we can quantify phenotypic stability and the histomorphology of cells used in tissue engineered medical products or use microcomputed tomography (micro-CT) imaging to non-destructively characterize the morphology of complex materials. The combined output of our work includes critical review of manufacturers' data, failure analyses, test method development, standards and guidance document development, and publications related to the public health impact of medical devices and materials.