MedTech Dive, January 10, 2020. FDA warning letters to medical device manufacturers slid by nearly 90% between 2015 and 2019, but may be set to rebound upward in 2020.
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Reports Of Patients’ Deaths Linked To Heart Devices Lurk Below Radar
Kaiser Health News, December 24, 2019. It is so problematic that the FDA continues to file thousands of reports of patients’ deaths related to medical devices out of the public eye.
Read More »Roundup 2019: Breast implants, mesh, paclitaxel-coated devices among hot topics at FDA expert panels
MedTech Dive, December 23, 2019. As the FDA approves medical devices, it is essential that the public is made aware of inadequate post-approval studies and spotty adverse event reporting.
Read More »Report Claims More Women than Men Injured by Medical Devices
Medical Plastics News, November 28, 2019. A report published by the International Consortium of Investigative Journalists has revealed more women than men have been injured by a medical device.
Read More »NCHR’s Comments on the Safer Technologies Program (STeP) for Medical Devices
November 18, 2019. We therefore respectfully urge the FDA to revise the proposed guidance in ways that ensure that all medical devices undergo more rigorous testing prior to being approved or cleared.
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