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In this tip sheet, prepared for Health Journalism 2015, investigative reporter Peter Eisler (@byPeterEisler) offers some resources for reporting on medical devices. In January 2015 Eisler reported that a deadly, antibiotic-resistant bacteria was being spread by the use of a type of hard-to-clean endoscope.
Medical devices are regulated by the FDA’s Center for Devices and Radiologic Health (CDRH). Oversight breaks into two general categories: pre-market review and approval, and post-market surveillance and control.
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