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.
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 ....
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