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CDRH Industry: Announcing the General Wellness: Policy for Low-Risk Devices Final Guidance and Webinar on September 1, 2016

CDRH Industry: Announcing the General Wellness: Policy for Low-Risk Devices Final Guidance and Webinar on September 1, 2016

  • matt@madebywink.com
  • July 28, 2016
  • News / US FDA

Today, the FDA issued a final guidance document titled General Wellness: Policy for Low-Risk Devices. The guidance explains that the FDA does not intend to actively regulate low-risk technologies that are…

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FDA Final Guidance Document: “Adaptive Designs for Medical Device Clinical Studies”

  • matt@madebywink.com
  • July 27, 2016
  • News / US FDA

Today, the FDA published the Adaptive Designs for Medical Device Clinical Studies Final Guidance.  It provides clarity on how to plan and implement adaptive designs for clinical studies used in medical…

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FDA Issues Draft Guidance on the Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)

FDA Issues Draft Guidance on the Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)

  • matt@madebywink.com
  • July 25, 2016
  • News / US FDA

Today, the U.S. Food and Drug Administration released a draft guidance document, “Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI).”  The Unique Device Identification System…

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CDRH Industry: FDA Issues Draft Guidance on the Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)

CDRH Industry: FDA Issues Draft Guidance on the Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)

  • matt@madebywink.com
  • July 25, 2016
  • News / US FDA

Today, the U.S. Food and Drug Administration released a draft guidance document, “Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI).”  The Unique Device Identification System…

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CDRH Industry: FDA announces the Final Guidance titled “Information to Support a Claim of Electromagnetic Compatibility of Electrically-Powered Medical Device”

  • matt@madebywink.com
  • July 8, 2016
  • News / US FDA

Today, the U.S. Food and Drug Administration is announcing the availability of the guidance titled “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Device.”  This final…

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Recent Posts

  • What You Need to Know About the FDA 510(k) Premarket Notification Process
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  • 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

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