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Sheetal.Pandey
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re: Industry group opposes FDA proposal
Sheetal.Pandey   9/29/2010 10:13:10 PM
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I guess FDA is taking necessary steps as with time tchnology has changed immensely. Its great to see the tight regulation they have in US on medical devices.

elctrnx_lyf
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Manager
re: Industry group opposes FDA proposal
elctrnx_lyf   9/28/2010 9:52:17 AM
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There is lot of work needs to be done by the medical device companies to understand the new class of devices and their regulations. Since the medical device companies have a internal quality regulatory system tailor made (developed) for their particular device they need to understand the new class clearly and develop the complete system again. This will not only be an expensive task but also will delay the projects.

elctrnx_lyf
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Manager
re: Industry group opposes FDA proposal
elctrnx_lyf   9/28/2010 9:48:15 AM
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Hi Rick, I couldn't understand why Advamed is opposing to this move if they proposed to FDA to create a special class of devices. --- From the article "AdvaMed proposed to the FDA in May it create a new class of regulated devices that use relatively new technologies or address new applications." --- If there is a need to create a special class of devices then it is good that FDA is acting on it. But if the new class includes expansive list then it puts lot of burden on the medical device manufacturers to assess the class of device ....

rick merritt
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Author
re: Industry group opposes FDA proposal
rick merritt   9/27/2010 11:38:13 PM
NO RATINGS
What are your concerns about the latest FDA proposals?



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