Posts Tagged ‘ regulation ’

Australia’s Version of FDA Lax on Medical Device Safety

Mar 6th, 2012 | By
Australia’s Version of FDA Lax on Medical Device Safety

With the global news about the defective French breast implants called PIP filled with industrial silicone, the Canberra Times (here), published in the capital city of Australia, takes a look at how medical devices reach the market there. Australia’s version of the U.S. Food and Drug Administration (FDA) is called the Therapeutic Goods Administration (TGA)
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Mesh / Medical Device News Desk

Oct 19th, 2011 | By
Mesh / Medical Device News Desk

Thanks for stopping by. Many years from now the public will probably look back and say “They put permanently implanted medical devices in people without any scientific review for safety? ” By then it may seem a perfectly normal question, but for now, Mesh/Medical Device News Desk (MDND) is devoted to telling the stories of
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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.