Posted by Michael Wonder on 22 Jan 2019
Statement from FDA Commissioner and Director of the Center for Devices and Radiological Health on latest steps to strengthen FDA’s 510(k) program for premarket review of medical devices
22 January 2019 - In 2018, the FDA’s Center for Devices and Radiological Health achieved several new milestones, including a record-setting year for approvals of novel medical devices.
We also focused 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.
We articulated those concepts early in the year as part of the FDA’s Medical Device Safety Action Plan and most recently with our announcement of changes to strengthen the 510(k) program. The Safety Action Plan described actions we’ve taken over the past several years to enhance device safety and outlined our vision for how the agency can build on these initiatives to further assure the safety and effectiveness of medical devices.
