Testing Material Stress on Bone
Material Stress on Bone. FDA's research is helping the medical community understand the response of medical devices and their constituent materials to applied stress for both pre-market evaluations and post-market reported adverse events. Materials being studied include metals and polymers, biological materials, and materials used in tissue-engineered scaffolds. Though the spectrum of relevant materials is broad, common stress analysis principles can be applied to evaluate their behavior. FDA has the ability 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. The United States is the global leader in medical device innovation and the Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is committed to assuring that American patients have timely access to important new technologies and next-generation products without compromising their safety. Each year, millions of American patients benefit from innovative medical devices that reduce suffering, treat previously untreatable conditions, extend lives, and improve public health. CDRH is responsible for advancing public health and facilitating innovation to help bring novel technologies to market and make the medical devices that are already on the market safer and more effective. February, 2011.
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