Food and Drug Administration: Difference between revisions

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[[Image:fda-logo.jpg|right|thumb]]
[[Image:fda-logo.jpg|right|thumb]]


The American Food and Drug Administration has approved several circumcision devices and products made from harvested infant foreskins.<ref name='fda-accucirc'>{{REFweb
The American Food and Drug Administration has approved several [[circumcision]] devices and products made from harvested infant [[Foreskin| foreskins]].<ref name='fda-accucirc'>{{REFweb
  |last=Brogdon
  |last=Brogdon
  |first=Nancy C.
  |first=Nancy C.
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  |accessdate=2011-03-06
  |accessdate=2011-03-06
}}</ref><ref name='fda-dermagraft-tc'>{{REFweb
}}</ref><ref name='fda-dermagraft-tc'>{{REFweb
  |quote=...fibroblast-derived temporary skin substitute for the treatment of partial-thickness burns that has been approved for marketing by the FDA.
  |quote=...fibroblast-derived temporary [[skin]] substitute for the treatment of partial-thickness burns that has been approved for marketing by the FDA.
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== Circumcision Injury Reports ==
== Circumcision Injury Reports ==
As far back as August 2000, the U.S. Food and Drug Administration issued a public health notice about the [[Mogen]] and [[Gomco]] clamps after receiving about 20 injury reports a year since 1996, including lacerations, hemorrhaging, penile amputation and urethral damage.<ref>{{REFnews
As far back as August 2000, the U.S. Food and Drug Administration issued a public health notice about the [[Mogen]] and [[Gomco]] clamps after receiving about 20 injury reports a year since 1996, including lacerations, hemorrhaging, penile [[amputation]] and urethral damage.<ref>{{REFnews
  |last=Hennessy-Fiske
  |last=Hennessy-Fiske
  |first=Molly
  |first=Molly
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  |Text=Consumer Reports also expressed concerns about the safety testing and risks associated with metal hips, surgical mesh and certain cardiac devices.
  |Text=Consumer Reports also expressed concerns about the safety testing and risks associated with metal hips, surgical mesh and certain cardiac devices.


Allergan and other companies that make medical devices comply with current federal regulations, noted Rita Redberg, a professor of medicine and cardiologist at the University of California, San Francisco. She said it's those lenient federal standards that are the problem.
Allergan and other companies that make medical devices comply with current federal regulations, noted Rita Redberg, a professor of medicine and cardiologist at the {{UNI|University of California|UCSF}}, San Francisco. She said it's those lenient federal standards that are the problem.


"What the device industry is doing is certainly legal," Redberg told the Times. "There needs to be congressional action to improve the requirements for the safety and effectiveness of high-risk medical devices. A lot of people have these devices or they are candidates for one."
"What the device industry is doing is certainly legal," Redberg told the Times. "There needs to be congressional action to improve the requirements for the safety and effectiveness of high-risk medical devices. A lot of people have these devices or they are candidates for one."