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    FDA to Further Investigate Implantable Devices Containing Certain Metals

    Following concerns and reported adverse events linking biological responses to certain types of materials in medical devices, the US Food and Drug Administration (FDA) said recently that it will further engage stakeholders to investigate metal-containing implants and dental amalgam. Part of that engagement will involve a public advisory committee meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee on 13-14 November, which will discuss the...
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    Patient Engagement in Device Trials: FDA Drafts Guidance

    The US Food and Drug Administration (FDA) on Monday released new draft guidance explaining how sponsors can improve the design and conduct of medical device clinical investigations by using patient experience, perspectives and other relevant information. The 10-page draft mainly addresses four questions: What approaches might sponsors use to engage patient advisors (defined by FDA as those who have dealt with or are dealing with a particular condition but are not inv...
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    First MDR Certificate Issued for Class III Device

    Notified body TÜV SÜD announced Thursday that it has issued the first Medical Devices Regulation (MDR) certificate for one of Germany-based Biotronik’s Class III (highest-risk category) medical devices, in addition to its quality management system. The newly certified device is Biotronik’s Renamic programmer software , which enables physicians to program and test implanted cardiac devices such as pacemakers, implantable cardioverter-defibrillators and cardiac resynchro...
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    EC Adds IMQ as Fourth Notified Body Designated Under MDR

    The European Commission (EC) on Tuesday added Milan, Italy-based IMQ Istituto to its list of notified bodies (NBs) designated under the new Medical Devices Regulation (MDR). The announcement does not come as a surprise, as Italy’s Ministry of Health announced in late July that IMQ met the requirements of the regulation. The EC had also previously indicated in its rolling plan,  updated last Monday , that four NBs have been designated. The other three NBs to be de...
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    Edwards Lifesciences Recalls Devices After 3 Deaths Reported

    The US Food and Drug Administration (FDA) recently announced a Class I recall of more than 700 Edwards Lifesciences’ IntraClude Intra-Aortic Occlusion Devices after receiving 22 complaints related to balloon rupture or puncture, including three deaths. The device is used in patients undergoing cardiopulmonary bypass — a technique described by FDA as when “a machine temporarily takes over the function of the heart and lungs during surgery. When the IntraClude balloon is ...
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    Concussion Assessments: FDA Warns Against Using Unapproved Devices

    The US Food and Drug Administration (FDA) on Wednesday warned against using a smartphone- or tablet-based app to assess whether an injured or possibly concussed person is suffering from a change in physical or mental status including vision, concentration, memory, balance and speech. After identifying several manufacturers marketing devices for concussion diagnosis, treatment or management without FDA’s approval or clearance, the agency said it issued a safety communica...
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    CDRH Warns of Device Supply Issues Following Suspension of Illinois Sterilization Facility

    Citing concerns of increased cancer risks, the Illinois Environmental Protection Agency (EPA) last month issued a seal order to halt any new sterilization cycles using ethylene oxide at a Sterigenics facility in Willowbrook, IL. “Recent elevated sampling results, along with Sterigenics' refusal to voluntarily suspend operations, have resulted in the issuance of the Seal Order,” the Illinois EPA said . Sterigenics, meanwhile, said in a statement: “The Illinois EPA’s ...
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    Bipartisan Group of Lawmakers Urge Permanent Repeal of Device Tax

    A bipartisan team of eight Congressional leaders are circulating a “Dear Colleague” letter to urge fellow members of Congress to permanently repeal of the 2.3% medical device excise tax before it is reinstated next year. The device tax has only been in effect for two years—between 2013 and 2015—since it was introduced in 2010 under the Affordable Care Act . From device firms and industry groups to patient advocacy groups and health research organizations, the push agai...
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    China’s NMPA Cites Overseas Device, IVD Companies

    China’s National Medical Products Administration (NMPA) published overseas inspection results in late January, highlighting 17 overseas medical device and IVD manufacturers that were cited, including BD and Boston Scientific.   Since November 2017, when NMPA began to publish overseas inspection results, a total of 41 manufacturers have been cited, according to ChinaMed Device, LLC, which is a medical device and IVD consulting firm based in Boston, and is a certified NM...
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    AdvaMed and AAMI Weigh FDA Draft Guidance on Voluntary Consensus Standards

    Medical device industry group AdvaMed and the Association for the Advancement of Medical Instrumentation (AAMI) are seeking additional information from the US Food and Drug Administration (FDA) on draft guidance related to the recognition and withdrawal of voluntary consensus standards. The 8-page draft from September describes the procedures that FDA follows and the actions the agency may take during its review and evaluation of requests for standards recognition or ...
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    PMA Denials: Why so Few?

    In the pharmaceutical industry, complete response letters, or rejections, are a common occurrence. And though they aren’t frequently explained in detail publicly, the public is still usually notified that the company has received such a letter. But in the world of medical devices, failing to win approval for a high-risk device is a much more closely held secret, and companies can withdraw their applications rather than be denied approval.   A Federal Register notice ...
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    Study Raises Questions Over FDA’s Handling of Adulterated Supplements

    A new study published in JAMA Network Open on Friday raises questions about the US Food and Drug Administration’s (FDA) oversight of adulterated dietary supplements.   The study, which analyzed data from FDA’s Tainted Products Marketed as Dietary Supplements database, found more than 776 instances of supplements containing hidden pharmaceutical ingredients from 2007-2016.   However, only 360 of the 776 adulterated supplements were subject to a voluntary recall, w...