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Medtronic: FDA should lower medtech hurdles

1/11/2011 07:00 AM EST
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DrQuine
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re: Medtronic: FDA should lower medtech hurdles
DrQuine   1/15/2011 6:15:14 PM
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It would seem that consideration of where a medical device is used might help determine the regulatory hurdles that should be required. A recall of an external medical appliance that is suffering excessive wear and potential premature failure is much less serious than the recall of a surgically implanted device or prosthesis that could require life threatening and extremely expensive surgery to remove and replace.

elctrnx_lyf
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re: Medtronic: FDA should lower medtech hurdles
elctrnx_lyf   1/13/2011 4:08:23 AM
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I can understand that considering the health care reforms announced by Obama governement might have resulted this. Many hospitals might pulled back to wait until the clear policies are in place. But In general the delays at FDA approval are causing big trouble to all the US Medical device manufacturers. What we need a good regulatory process but again it should be quicker.

krisi
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re: Medtronic: FDA should lower medtech hurdles
krisi   1/12/2011 3:59:37 AM
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I am surpised too that the medical market suffered in 2010 as much as Medtronic is saying, I thought they would be quite immune to that...but I am not nervous as selinz in regards to streamlining regulatory process, people always have an option of not using the technology if they don't want to...Kris

selinz
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re: Medtronic: FDA should lower medtech hurdles
selinz   1/12/2011 12:14:11 AM
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I have been under the impression that the medical industry has been somewhat immune from the downturn. This article suggests otherwise... However, I'm nervous about decreasing hurdles with items having to do with health. A comparable issue is the current process of getting new drugs throught the regulatory process. Do we want that process streamlined?

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