New eMDR Webpages Available to Help with Submissions

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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 and how to submit medical device reports electronically. On August 14, 2015, the eMDR final rule went into effect, requiring manufacturers and importers […]

CDRH Industry: Update to Final Guidance Document: “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile”

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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 The guidance was updated to correct an inadvertent editorial change from the draft guidance that might be interpreted as a recommendation to submit data on endotoxin levels per device as unit/device rather […]

Announcing Draft Guidance on UDI: Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices

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Today, the Food and Drug Administration (FDA) released a draft guidance document, “Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices; Draft Guidance for Industry and Food and Drug Administration Staff.” Medical devices currently available through a pharmacy and potentially eligible for reimbursement from payers are generally labeled […]

Announcing Draft Guidance on Interoperable Medical Devices

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Today, the FDA issued draft guidance: Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices to provide clarity on how the agency evaluates medical devices that electronically connect and interact with other devices or systems. This guidance provides manufacturers with design considerations for developing interoperable medical devices and recommendations on information to include in pre-market submissions […]

Announcing Final Guidance Document: “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile” – Webinar February 11, 2016

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Today, the U.S. Food and Drug Administration issued final guidance document, “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile” .  Its recommendations seek to ensure that manufacturers incorporate adequate sterilization methods for 510(k) devices labeled as sterile and provide appropriate documentation and information to the FDA for premarket review […]

Announcing Draft Guidance on Unique Device Identification: Convenience Kits

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Today the FDA released a draft guidance document, “Unique Device Identification: Convenience Kits – Draft Guidance for Industry and Food and Drug Administration Staff ”. This document is intended to outline the agency’s proposed interpretation that the term “convenience kit”, as defined by 21 CFR 801.3, applies solely to two or more different medical devices packaged […]

Updates to FDA’s eCopy Guidance

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On December 3, 2015, the FDA’s Center for Devices and Radiological Health (CDRH) issued a revised version of the guidance document, “eCopy Program for Medical Device Submissions,” that clarifies certain aspects of the prior guidance. This guidance replaces the prior version of this guidance issued on October 10, 2013. The purpose of this guidance is […]