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FDA Issues Draft Guidance for 510(k) Third Party (TP) Review Program

FDA Issues Draft Guidance for 510(k) Third Party (TP) Review Program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Today, the U.S. Food and Drug Administration (FDA) released a draft guidance document entitled “510(k) Third Party Review Program.” The purpose of this draft guidance is to explain the FDA’s…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CDRH Industry: FDA Announcing Two Draft Guidance Documents Clarifying When to Submit a 510(k) for a Change to an Existing Device and Webinar on August 25, 2016

CDRH Industry: FDA Announcing Two Draft Guidance Documents Clarifying When to Submit a 510(k) for a Change to an Existing Device and Webinar on August 25, 2016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Today the FDA released two draft guidance documents: “Deciding When to Submit a 510(k) for a Change to an Existing Device,” which applies to medical device changes broadly, and “Deciding…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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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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CDRH Industry: Announcing FDA Final Guidance and Webinar on “Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices”

  • matt@madebywink.com
  • June 21, 2016
  • News / US FDA

Today the FDA published a final guidance, which provides a framework to consider extrapolating existing data to evaluate a device’s performance in pediatric patients in pre-market approval applications (PMAs), humanitarian device…

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FDA Releases “Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies” Draft Guidance

  • matt@madebywink.com
  • June 17, 2016
  • News / US FDA

Today we released the “Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies” draft guidance, which provides recommendations to improve the quality, consistency and transparency…

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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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