Modernizing FDA’s program for the safety and effectiveness of medical devices

Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices
The technological advances in medical devices and their ability to improve the lives of patients are creating tremendous public health promise. But as physicians, we also understand the real harm that devices may cause if they malfunction, are misused, or are made of poor quality.

The continued integrity of the 510(k) program, as a means to assure the safety and effectiveness of devices, is a top priority for us, and for the FDA. Part of our commitment to protect patients is to recognize that all devices pose benefits and risks, and to seek ways to minimize those risks.

We’re seizing the chance to make a generational change in the framework for 510(k) reviews – one that advances its best features while making sure it keeps pace with modern innovation.

Author(s) Source
FDA Statement, Gottlieb S, Shuren J FDA website, Nov 26, 2018
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