FDA Addresses Device Safety Process, But Will It Be Enough?


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  • Jun 04, 2019

The FDA has announced that its Center for Devices and Radiological Health achieved several new milestones in late 2018 aimed at making medical devices safer, as well as giving healthcare administrations more input in what devices should be approved.

The FDA, in a written statement, touted its “record-setting year” for approvals of novel medical devices, as well as focusing on advancing several meaningful initiatives and policy proposals aimed at enhancing the safety of medical devices, including the safety of devices cleared through the FDA’s 510(k) review process before going to market.

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