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Announcing Final Guidance Document: “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile” – Webinar February 11, 2016

Announcing Final Guidance Document: “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile” – Webinar February 11, 2016

  • Admin
  • February 11, 2016
  • News / US FDA

Today, the U.S. Food and Drug Administration issued final guidance document, “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile” .  Its recommendations seek to…

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Announcing Draft Guidance on UDI: Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices

Announcing Draft Guidance on UDI: Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices

  • Admin
  • February 2, 2016
  • News / US FDA

Today, the Food and Drug Administration (FDA) released a draft guidance document, “Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices; Draft Guidance…

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