US FDA Publishes Material Safety Data to Promote Safer, More Effective Medical Devices

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The following quote is attributed to Ed Margerrison, Ph.D., director of the Office of Science and Engineering Laboratories in the FDA’s Center for Devices and Radiological Health.

“As part of the FDA’s ongoing commitment to promote the greater safety of medical devices, we have partnered with ECRI to study and publish safety profiles for materials that are commonly used in implantable medical devices and the effects of those materials on patients over time. These evaluations are part of the FDA’s broader initiative to improve the safety of medical devices through the use of safer materials and preventing patients at risk for an adverse response to select materials from receiving devices that contain them.

The FDA believes this information will be a useful tool for innovators in selecting materials and components for future medical products, resulting in patients and doctors having better access to more effective and safer medical devices. Additionally, this work will help increase transparency, minimize patient risk and have a profound impact on patient health.

A key objective of the FDA is to continually improve the quality of life for U.S. patients. We are pleased to be at the forefront of supporting this era of medical device innovation while maintaining patient safety. We know that both work in tandem to bring access to safe and effective medical devices. One of the many ways that the FDA can help to stimulate innovation in products is to use its unique position to help innovators make better choices early in product development, which results in improved safety and effectiveness of medical devices.”



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