Statement from FDA Commissioner and Director of the Center for Devices and Radiological Health on efforts to evaluate materials in medical devices to address potential safety questions

FDA

15 March 2019 - We’re in an unprecedented era of innovation in medical devices with advances in materials science that have led to technological breakthroughs such as the 3D printing of medical devices, continuous glucose monitoring patches for diabetes and miniaturised brain implants to treat epilepsy and Parkinson’s disease. 

Helping to ensure patients have access to safe medical devices that improve function and overall quality of life is a crucial part of the mission of the U.S. FDA. 

Our regulatory framework is designed to ensure that benefits patients receive from these devices are weighed against probable risks.

Read FDA Statement

Michael Wonder

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Michael Wonder

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US , Regulation , Device