Statement from Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on continued efforts to evaluate materials in medical devices to address potential safety questions

Statement from Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on continued efforts to evaluate materials in medical devices to address potential safety questions

Innovation in medical devices, spurred in many cases by advances in materials sciences, continues to improve the lives of patients. The growing number of available materials used in today’s medical devices ‒ such as metal, plastic, silicone, animal-derived products or some combination of these ‒ reflects continued evolution in this field that the U.S. Food and Drug Administration has routinely worked to evaluate as part of our ongoing commitment to foster safety and innovation to ensure that patients have access to safe and effective medical devices. As part of our role in protecting patients, our staff regularly evaluates and monitors scientific evidence, as well as adverse event reports, to learn more about risks from devices—including those that may be related to the materials used in devices. In the case of medical device implants where materials may...

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