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MDUFMA

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MDUFMAMedical Device User Fee and Modernization Act


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While MDUFMA I did include important provisions to ensure that smaller companies received fee relief, including a onetime waiver of fees for an initial PMA and reduced application fees for 510(k)s, PMAs and PMA supplements, it started the slippery slope of government reliance on industry fees.
24) Congress itself acknowledged as much in the report on the legislation that MDUFMA was enacted "in order to provide the Food and Drug Administration (FDA) with the resources necessary to better review medical devices .
MDUFMA had a big impact--the timelines are onerous," she said, referring to medical device user fees.
 
 
 
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