Study on Medical Device Recalls Released

Archives of Internal Medicine, February 14, 2011. Our study finds that most medical devices recalled during the last five years for “serious health problems or death” were originally cleared (approved) by the Food and Drug Administration (FDA) using a less stringent process that does not require testing in patients.

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Regulatory Reticence and Medical Devices

The Milbank Quarterly, March 6, 2014. Our analysis of the recent history of device regulation in the United States, however, leads to a less optimistic conclusion: that these changes in regulatory policy fail to adequately address the central shortcoming in the regulation of medical devices in the United States and Europe.

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