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10 Unsafe Medical Devices That Hit the Market
March 28, 2015
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10 Unsafe Medical Devices That Hit the MarketMarch 27, 2015Being an FDA regulator must be a thankless job. Critics from the medtech industry often say you are clearing products too slowly, while patient advocates allege you are not clearing products carefully enough.While the majority of medical devices that hit the market—both in the United States and other developed geographies like Europe—are safe and effective, dangerous products occasionally make it to the market.One example includes an Olympus endoscope related to superbug deaths, which somehow hit the market without FDA clearance.Here are 10 devices that may have needed more regulatory oversight>>Brush up on your regulatory affairs knowledge at MD&M West, February 9–11 at the Anaheim Convention Center in Anaheim, CA. Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarkerLike what you’re reading? Subscribe to our daily e-newsletter.
10 Unsafe Medical Devices That Hit the Market
March 27, 2015
Being an FDA regulator must be a thankless job. Critics from the medtech industry often say you are clearing products too slowly, while patient advocates allege you are not clearing products carefully enough.
While the majority of medical devices that hit the market—both in the United States and other developed geographies like Europe—are safe and effective, dangerous products occasionally make it to the market.
One example includes an Olympus endoscope related to superbug deaths, which somehow hit the market without FDA clearance.
Here are 10 devices that may have needed more regulatory oversight>>
Brush up on your regulatory affairs knowledge at MD&M West, February 9–11 at the Anaheim Convention Center in Anaheim, CA. |
Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker
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