Senate Passes Unprecedented Medical Device User Fee Act

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The senate passed new legislation, June 26, that reauthorizes the latest version of the user fee bill.  The bill introduces performance goals for the FDA.  The bill nearly doubles the fees paid by medical device manufacturers.  Medical device Manufacturers are  required to pay fees for certain services that include 510(k) and PMA submissions and establishment registration.  The bill seems to be supported by most of the industry as a positive step for shorter review times and encouraging product innovation.  Read the entire article here.

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