Food and Drug Administration: Difference between revisions
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|publisher=Los Angeles Times | |publisher=Los Angeles Times | ||
|quote=As far back as August 2000, the U.S. Food and Drug Administration issued a public health notice... | |quote=As far back as August 2000, the U.S. Food and Drug Administration issued a public health notice... | ||
|accessdate=2011-09-25}}</ref> Instead of recalling the devices, the FDA advised users to make sure they were using the devices according to the manufacturer's specifications.<ref>{{REFnews | |accessdate=2011-09-25 | ||
}}</ref> Instead of recalling the devices, the FDA advised users to make sure they were using the devices according to the manufacturer's specifications.<ref>{{REFnews | |||
|last=Hennessy-Fiske | |last=Hennessy-Fiske | ||
|first=Molly | |first=Molly | ||
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|publisher=Los Angeles Times | |publisher=Los Angeles Times | ||
|quote=Instead of recalling the devices, the FDA advised users to make sure... | |quote=Instead of recalling the devices, the FDA advised users to make sure... | ||
|accessdate=2011-09-25}}</ref> The agency also cautioned against using replacement parts on the Gomco clamp, which led it to malfunction.<ref>{{REFnews | |accessdate=2011-09-25 | ||
}}</ref> The agency also cautioned against using replacement parts on the Gomco clamp, which led it to malfunction.<ref>{{REFnews | |||
|last=Hennessy-Fiske | |last=Hennessy-Fiske | ||
|first=Molly | |first=Molly | ||
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|publisher=Los Angeles Times | |publisher=Los Angeles Times | ||
|quote=The agency also cautioned against using replacement parts on the Gomco clamp... | |quote=The agency also cautioned against using replacement parts on the Gomco clamp... | ||
|accessdate=2011-09-25}}</ref> In the 11 years following the FDA warnings, the agency has received 139 additional reports of problems related to circumcision clamps, including 51 injuries.<ref>{{REFnews | |accessdate=2011-09-25 | ||
}}</ref> In the 11 years following the FDA warnings, the agency has received 139 additional reports of problems related to circumcision clamps, including 51 injuries.<ref>{{REFnews | |||
|last=Hennessy-Fiske | |last=Hennessy-Fiske | ||
|first=Molly | |first=Molly | ||
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|publisher=Los Angeles Times | |publisher=Los Angeles Times | ||
|quote=In the 11 years following the FDA warnings, the agency has received 139 additional reports... | |quote=In the 11 years following the FDA warnings, the agency has received 139 additional reports... | ||
|accessdate=2011-09-25}}</ref> Twenty-one of those reports were related to [[Mogen]] clamps, all but one of which involved injuries.<ref>{{REFnews | |accessdate=2011-09-25 | ||
}}</ref> Twenty-one of those reports were related to [[Mogen]] clamps, all but one of which involved injuries.<ref>{{REFnews | |||
|last=Hennessy-Fiske | |last=Hennessy-Fiske | ||
|first=Molly | |first=Molly | ||
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|publisher=Los Angeles Times | |publisher=Los Angeles Times | ||
|quote=Twenty-one of those reports were related to Mogen clamps... | |quote=Twenty-one of those reports were related to Mogen clamps... | ||
|accessdate=2011-09-25}}</ref> | |accessdate=2011-09-25 | ||
}}</ref> | |||
== Products & Devices == | == Products & Devices == | ||
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| last= | | last= | ||
| first= | | first= | ||
| date= | | date=2012-03 | ||
| title=Report Slams Approval Process for Medical Devices | | title=Report Slams Approval Process for Medical Devices | ||
| url=http://www.webcitation.org/66VuXY3Us | | url=http://www.webcitation.org/66VuXY3Us | ||
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| last= | | last= | ||
| first= | | first= | ||
| date= | | date=2012-07 | ||
| title=FDA Conducted Surveillance Operation Against Scientists | | title=FDA Conducted Surveillance Operation Against Scientists | ||
| url=http://www.webcitation.org/69DN3PuxD | | url=http://www.webcitation.org/69DN3PuxD | ||
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|last= | |last= | ||
|first= | |first= | ||
|date= | |date=2011-12 | ||
|title=Vulnerabilities in FDA's Oversight of State Food Facility Inspections Report (OEI-02-09-00430) | |title=Vulnerabilities in FDA's Oversight of State Food Facility Inspections Report (OEI-02-09-00430) | ||
|url=http://oig.hhs.gov/oei/reports/oei-02-09-00430.pdf | |url=http://oig.hhs.gov/oei/reports/oei-02-09-00430.pdf | ||
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| last= | | last= | ||
| first= | | first= | ||
| date= | | date=2012-06 | ||
| title=Scientific Disagreements Regarding Medical Device Regulatory Decisions (Report OEI-01-10-00470) | | title=Scientific Disagreements Regarding Medical Device Regulatory Decisions (Report OEI-01-10-00470) | ||
| url=http://oig.hhs.gov/oei/reports/oei-01-10-00470.pdf | | url=http://oig.hhs.gov/oei/reports/oei-01-10-00470.pdf | ||