Meeting Notice: February 20, 2015 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-0001] Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Postponement of Meeting AGENCY:  Food and Drug Administration, HHS. ACTION:  Notice. SUMMARY:  The Food and Drug Administration (FDA) is postponing the meeting of the Orthopaedic and Rehabilitation Devices Panel…

Consumer Information on: Barostim neo Legacy System

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Webcast and Presentations Added to the Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) Public Workshop, January 8-9, 2015

The purpose of this workshop was to discuss FDA’s proposal for a risk-based framework for addressing the regulatory oversight of a subset of in vitro diagnostic devices (IVDs) referred to as laboratory developed tests (LDTs), which are intended for clinical use and designed, manufactured and used within a single laboratory, and provide an additional opportunity…

Webinars: UDI 101 and Getting Ready for GUDID

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Class I Medical Device Recall: Alere San Diego Inc., Alere INRatio and INRatio2 PT/INR Monitor System (Professional and Prescription Home Use)

Recall Class: Class I Date Recall Initiated: December 5, 2014 Devices: Alere INRatio and INRatio2 PT/INR Monitor System (Professional and Prescription Home Use) INRatio Monitor or INRatio2 Monitor INRatio Test Strips Manufacturing and Distribution Dates: April 1, 2008 to December 4, 2014 Related Class I Recall for Professional INRatio2/INR Test Strips Use: The Alere INRatio…

Webinar: FDA's Medical Device Clinical Trials Program

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