Who owns the 510(k)?

نویسنده

  • Maria E Donawa
چکیده

Unfortunately, some medical device manufacturers, particularly those based outside the United States (US) are unaware of the business implications of submitting a 510(k) premarket notification to the US Food and Drug Administration. This article discusses information regarding the ownership and other business related aspects of filing a 510(k).

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عنوان ژورنال:
  • Medical device technology

دوره 19 2  شماره 

صفحات  -

تاریخ انتشار 2008