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    FDA Finalizes Guidance on Convenience Kit UDI Marking

    The US Food and Drug Administration (FDA) issued final guidance Thursday to provide medical device manufacturers clarifications on unique device identification (UDI) marking policies for convenience kits. The guidance finalized the 2016 draft version of the document, developed by FDA’s Center for Devices and Radiological Health and its Center for Biologics Evaluation and Research. Combination products and in vitro diagnostics subject to labeling requirements fall ou...
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    FDA Finalizes Guidance on Pediatric Information in Drug Labels

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance on the content and placement of pediatric information within the labeling of drugs and biologics.   “The goal of this guidance is to provide recommendations to help ensure that information on the use of prescription drugs in pediatric populations (whether positive, negative, or inconclusive) is consistently placed in the proper sections and subsections within labeling so that the information is c...
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    FDA Draft Guidance on Broader Labeling for Oncology Companion Diagnostics Draws Mixed Reactions

    Developers of companion diagnostic (CDx) tests as well as pharmaceutical and biotechnology groups and companies expressed mixed reactions to the US Food and Drug Administration (FDA) draft guidance on broader labeling of in vitro CDx assays for a specific group or class of oncology therapeutic products. The support and concerns were expressed through comments recently submitted to FDA’s draft guidance document, which was released  last December. Some commenters showe...
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    WHO Advances International Harmonized Nomenclature for Medical Devices

    The World Health Organization (WHO) reported Monday on recent progress toward the development of its international nomenclature for medical devices, known as the International Classification of Medical Devices (ICMD). WHO discussed work in progress at the 4th Global Forum on Medical Devices, which took place last December. “Having a nomenclature system in place for medical devices facilitates their management and regulation by standardizing terms that enable communic...
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    US, EU Pledge to Cooperate on UDI Specifications

    The US and EU will cooperate to ensure alignment of electronic database specifications for Unique Device Identifiers (UDIs) and will develop a bilateral test of compatibility of respective UDI databases, according to the interim report on the work of the US-EU Executive Working Group (EWG) on trade. The report said such cooperative work will be in concert with ongoing efforts from the International Medical Device Regulators Forum (IMDRF), which consulted on UDIs in 20...
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    FDA Finalizes Accelerated Approval Labeling Guidance

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance on labeling drugs and biologics approved under the accelerated approval pathway.   FDA's accelerated approval program allows the agency to approve products to treat serious or life-threatening conditions based on surrogate or intermediate clinical endpoints "that are reasonably likely to predict clinical benefit." When granting accelerated approval, FDA will require a sponsor to complete postmarket...
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    FDA Drafts Guidance on Oncology Companion Diagnostics

    The US Food and Drug Administration (FDA) said it was encouraged to help guide developers of companion diagnostics toward newly drafted policies in support of broader labeling. “We’re concerned that the situation is not optimal for patient care because a clinician may need to order a different companion diagnostic, obtain an additional biopsy from a patient or both, to have additional therapy treatment options,” US Food and Drug Administration (FDA) Commissioner Scott G...
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    Medtronic Fronts $51M to Resolve DOJ Case Over Unapproved Device Uses

    Medtronic agreed to pay $51 million in a case brought on by the US Department of Justice (DOJ) over introducing an adulterated medical device into interstate commerce. At the center of the off-label marketing litigation is the US Food and Drug Administration's (FDA) 2005 premarket approval on an use indication for a neurovascular device manufactured by ev3, which was acquired  by Covidien in 2010, which Medtronic acquired  in 2015.  ev3 launched a sales and marketi...
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    Manufacturers of Thermal Therapy Devices Look to Mitigate Risk of Tissue Overheating

    Medtronic and Monteris Medical are suggesting procedural techniques to reduce unintended thermal damage linked to their magnetic resonance-guided laser interstitial thermal therapy devices, the US Food and Drug Administration (FDA) said Thursday.   The agency summarized the new information from both medical device manufacturers and provided updated recommendations in two letters to health care providers. Medtronic issued three advisory letters between June and August t...
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    Pfizer and Mylan Report EpiPen Label Defect Could Delay, Prevent Emergency Use

    The US Food and Drug Administration (FDA) recently issued a safety alert to inform that EpiPen manufacturer, Pfizer, has become aware that the label sticker on certain auto-injectors “may have been improperly applied, causing resistance when removing it from the carrier tube.”   The safety alert affects Mylan’s EpiPen 0.3 mg and EpiPen Jr 0.15 mg containing labeled expiries on both the devices and cartons between June 2018 and February 2020 and between October 2018 a...
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    FDA Flags Violations at Medical Device Firms in Sweden, Canada, Spain, UK

    Device firms in Sweden, Canada, Spain and the UK separately drew four US Food and Drug Administration (FDA) warning letters over good manufacturing practice (GMP) violations.   The GMP violations cited in the warning letters posted Tuesday stem from inspectional observations first noted in FDA Form 483s issued to each of the four device manufacturing facilities, following the site visits investigators conducted during 2017 and 2018.   Most of the firms issued res...
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    First Version of NEST to Launch in 2019

    The National Evaluation System for health Technology (NEST) will become increasingly crucial for tracking medical devices at FDA’s Center for Devices and Radiological Health (CDRH), though its creation continues to be fraught with limitations. The timeline for an initial version of the NEST Coordinating Center (NESTcc) is tight, Rachel Fleurence, NESTcc executive director, noted Wednesday at the MDEpiNet annual meeting at FDA’s White Oak campus. The idea for NEST origina...