FDA announces plans to modernize 510(k) pathway for medical devices

FDA Commissioner Scott Gottlieb, MD, and Jeff Shuren, MD, director of the Center for Devices and Radiological Health, released a statement regarding changes being made to modernize the FDA 510(k) clearance pathway to help keep pace with the increasing complexity of rapidly evolving technology. These changes to the 510(k) clearance pathway are part of the Medical Device Safety Action Plan issued by FDA in April 2018.
“The new technology that we’re seeing holds tremendous public health promise for patients. But with the advances also come new complexities that can make (Read more...)

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