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Announcing Draft Guidance on Unique Device Identification: Convenience Kits

Announcing Draft Guidance on Unique Device Identification: Convenience Kits

  • matt@madebywink.com
  • December 31, 2015
  • News / US FDA

Today the FDA released a draft guidance document, “Unique Device Identification: Convenience Kits – Draft Guidance for Industry and Food and Drug Administration Staff ”. This document is intended to outline…

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Updates to FDA’s eCopy Guidance

  • matt@madebywink.com
  • December 7, 2015
  • News / US FDA

On December 3, 2015, the FDA’s Center for Devices and Radiological Health (CDRH) issued a revised version of the guidance document, “eCopy Program for Medical Device Submissions,” that clarifies certain…

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