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New eMDR Webpages Available to Help with Submissions

New eMDR Webpages Available to Help with Submissions

  • matt@madebywink.com
  • 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”

  • matt@madebywink.com
  • 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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  • The FDA Medical Device Approval Timeline: How Long Does it Take?
  • When’s the Right Time to Hire an FDA Regulatory Consultant?
  • Understanding Regulatory Strategy For A New Medical Device
  • What Is Software as a Medical Device?

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