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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
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 Subject :US FDA Warning Letters in Clinical Investigation for the Month of Dece.. 2009-12-31 17:10:00 
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Subject :US FDA Warning Letters in Clinical Investigation for the Month of December 2009

Dear Friends,

Please find attached US FDA warning letter for the month of December 2009.

Thanks and regards,



Attachments
 December 2009.pdf [25 KB] ::
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