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New eMDR Webpages Available to Help with Submissions

New eMDR Webpages Available to Help with Submissions

  • Admin
  • March 31, 2016
  • News / US FDA

The FDA has added new information on our webpages about adverse event reporting requirements. The Electronic Medical Device Reporting (eMDR) System webpages help manufacturers, importers and health care facilities understand eMDR requirements…

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CDRH Industry: Update to Final Guidance Document: “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile”

CDRH Industry: Update to Final Guidance Document: “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile”

  • Admin
  • March 17, 2016
  • News / US FDA

On March 16, 2016, the FDA posted an updated version of the Sterility Final Guidance, originally published as final on January 21, 2016. The guidance was updated to correct an inadvertent…

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Announcing Draft Guidance on UDI: Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices

Announcing Draft Guidance on UDI: Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices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Today, the Food and Drug Administration (FDA) released a draft guidance document, “Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices; Draft Guidance…

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Announcing Draft Guidance on Interoperable Medical Devices

Announcing Draft Guidance on Interoperable Medical Devices

  • Admin
  • January 25, 2016
  • News / US FDA

Today, the FDA issued draft guidance: Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices to provide clarity on how the agency evaluates medical devices that electronically connect and interact with…

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Announcing Draft Guidance on Unique Device Identification: Convenience Kits

Announcing Draft Guidance on Unique Device Identification: Convenience Kits

  • Admin
  • 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

Updates to FDA’s eCopy Guidance

  • Admin
  • 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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A Wright Path® Launches Consultancy Firm to Help Businesses Navigate Global Regulatory Environment

A Wright Path® Launches Consultancy Firm to Help Businesses Navigate Global Regulatory Environment

  • Admin
  • July 8, 2015
  • News

I am pleased to tell you about the exciting new developments at A Wright Path®, a reliable name in global regulatory compliance and strategy. We recently launched a new website…

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Recent Posts

  • Advice from Experts on Getting Your Start Up Medical Device on the Path to Success
  • FDA announces final guidance and upcoming webinar on Medical Device Reporting for Manufacturers
  • CDRH Industry: The FDA Launches New Webpage for Reporting Allegations of Regulatory Misconduct
  • CDRH Industry: FDA Updates Expedited Access Pathway (EAP) Program website
  • FDA Issues Draft Guidance for 510(k) Third Party (TP) Review Program

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