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

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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 adverse events and malfunctions. There have been numerous changes to the medical device reporting requirements since the FD&C Act first described them and the Medical […]

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

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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 that violates the law. The website explains the process for submitting allegations to the Center for Devices and Radiological Health (CDRH) and contains a form to […]

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

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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 issued the Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions […]

FDA Issues Draft Guidance for 510(k) Third Party (TP) Review Program

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Today, the U.S. Food and Drug Administration (FDA) released a draft guidance document entitled “510(k) Third Party Review Program.” The purpose of this draft guidance is to explain the FDA’s 510(k) Third Party (TP) Premarket Review Program, formerly known as the Accredited Persons (AP) Program. Under the FDA’s TP Premarket Review Program, authorized by federal […]

CDRH Industry: FDA Announcing Two Draft Guidance Documents Clarifying When to Submit a 510(k) for a Change to an Existing Device and Webinar on August 25, 2016

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Today the FDA released two draft guidance documents: “Deciding When to Submit a 510(k) for a Change to an Existing Device,” which applies to medical device changes broadly, and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device,” which focuses on software-specific changes. Medical device technology is constantly evolving, and […]

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

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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 intended only for general wellness use.  The FDA encourages the development of general wellness technologies, such as fitness trackers or mobile apps, which can empower […]

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

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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 device development.  This final guidance applies to premarket medical device submissions including premarket approval applications (PMA), premarket notification (510(k)) submissions, de novo submissions, humanitarian device […]

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

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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 Rule (UDI Rule) requires the label and device packages of most medical devices to bear a unique device identifier (UDI) in both easily readable plain-text […]

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

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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 Rule (UDI Rule) requires the label and device packages of most medical devices to bear a unique device identifier (UDI) in both easily readable plain-text […]

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

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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 guidance provides FDA’s current thinking about the information that should be provided in a premarket submission to support a claim of EMC for an electrically-powered […]