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  • I received another report of 5 years since the last inspection, plus an observation that FDA's budget for inspection of Class I devices is $0. And Ginger is not alone in thinking that there may be some geographical differences in frequency of inspections, which reflect differences in FDA resources available from district to district around the country....

  • Can anyone point me to labeling requirement for Class 1 devices, both on the device and the accompanying paperwork, for USA and EU? ------------------------------ Samir Shah Miami FL United States

  • Julie, Based on tone of your questions, I presumed you may be answering to potential client's questions. During pre-start up phase, it is reasonable to perform "regulatory shopping." I suppose you will provide some actionable direction so that your prospective client can make an informed decision when they are funded. ...

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