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FDA Week - 05/10/2019

FDA To End Hidden Reporting For Breast Implants, All Medical Devices

By David Roza
May 6, 2019 at 6:49 PM
FDA will take a range of actions to increase the agency’s uptake of breast implant adverse event reports and registry data, and will also make sure patients and providers are aware of the potential risks of such products by publicizing adverse events that were in a hidden database. The actions, which do not entail a ban or sales restrictions, are part of the agency’s broader efforts to end summary reporting for all medical devices -- a process that has come...


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