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Advice from Experts on Getting Your Start Up Medical Device on the Path to Success

Advice from Experts on Getting Your Start Up Medical Device on the Path to Success

  • matt@madebywink.com
  • March 29, 2018
  • News

As a new medical device start up, the process of making your product compliant might seem daunting, but it doesn’t have to be. The experts in the field have some…

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FDA announces final guidance and upcoming webinar on Medical Device Reporting for Manufacturers

FDA announces final guidance and upcoming webinar on Medical Device Reporting for Manufacturers

  • matt@madebywink.com
  • November 7, 2016
  • News / US FDA

Today, the FDA issued final guidance on Medical Device Reporting for Manufacturers.  This guidance document is intended to assist medical device manufacturers meet applicable reporting and recordkeeping requirements for certain device-related…

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CDRH Industry: The FDA Launches New Webpage for Reporting Allegations of Regulatory Misconduct

CDRH Industry: The FDA Launches New Webpage for Reporting Allegations of Regulatory Misconduct

  • matt@madebywink.com
  • October 24, 2016
  • News / US FDA

Today the FDA launched a webpage on Allegations of Regulatory Misconduct, which are claims that a medical device manufacturer or individuals marketing medical devices may be doing so in a manner…

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CDRH Industry: FDA Updates Expedited Access Pathway (EAP) Program website

CDRH Industry: FDA Updates Expedited Access Pathway (EAP) Program website

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

Today, the U.S. Food and Drug Administration updated the Expedited Access Pathway Program website with two Data Development Plan examples that serve as a resource for sponsors. In April 2015, the FDA…

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FDA Issues Draft Guidance for 510(k) Third Party (TP) Review Program

FDA Issues Draft Guidance for 510(k) Third Party (TP) Review Program

  • matt@madebywink.com
  • September 9, 2016
  • News / US FDA

Today, the U.S. Food and Drug Administration (FDA) released a draft guidance document entitled “510(k) Third Party Review Program.” The purpose of this draft guidance is to explain the FDA’s…

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CDRH Industry: FDA Announcing Two Draft Guidance Documents Clarifying When to Submit a 510(k) for a Change to an Existing Device and Webinar on August 25, 2016

CDRH Industry: FDA Announcing Two Draft Guidance Documents Clarifying When to Submit a 510(k) for a Change to an Existing Device and Webinar on August 25, 2016

  • matt@madebywink.com
  • August 5, 2016
  • News / US FDA

Today the FDA released two draft guidance documents: “Deciding When to Submit a 510(k) for a Change to an Existing Device,” which applies to medical device changes broadly, and “Deciding…

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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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More to Explore

  • How an Effective FDA Regulatory Strategy Can Streamline FDA Approval and Clearance
  • 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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