The Problem with Medical Device Approval

MedShadow, January 16, 2018. To get FDA approval for a medical device, a company needs to say that its device is “substantially equivalent” to an existing one. Devices might be easily approved without further safety and effectiveness studies.

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EpiPen Failures Cited in Seven Deaths This Year, FDA Files Show

Bloomberg News, November 2 2017: FDA reports reveal that EpiPen failures have been associated with seven deaths and 35 hospitalizations, highlighting serious concerns about the device’s reliability. The National Center for Health Research emphasized the urgent need for thorough investigations and improved safety measures to ensure the effectiveness of this critical allergy treatment.

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