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    FDA Designates QIAGEN Recall, Centurion Recall

    The US Food and Drug Administration (FDA) classified on Friday a QIAGEN recall of filter-tips used with two QIAGEN assays indicated for monitoring treatment of a common virus and evaluating blood cancers, as well as a Centurion Medical Products recall of airways kits containing Teleflex endotracheal tubes and connectors.  Following a 5 June correction letter that QIAGEN sent to its laboratory customers, the agency is now identifying QIAGEN's recall as Class I. The recal...
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    EU MDR/IVDR: US Raises ‘Serious Concerns,’ Urges 3-Year Implementation Delay

    The US raised “serious concerns” with several issues regarding the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR) and called on the EU to delay MDR/IVDR implementation by three years. In a 24 July statement to the World Trade Organization’s (WTO) Committee on Technical Barriers to Trade, the US discusses the MDR/IVDR issues facing industry. “Our industry is worried about their continued access to the EU's USD 125 billion medical device market, USD ...
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    FDA Updates Guidance on Devices in the Magnetic Resonance Environment

    Draft guidance issued on Thursday offers updated testing and labeling advice to assess the safety and compatibility of medical devices for the magnetic resonance (MR) environment.   Once finalized, the 26-page draft guidance from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) will supersede a final guidance issued in 2014. The recommendations in the new draft guidance go beyond those set forth in 2014, particularly as it r...
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    New FDA Guidances Target Women’s Health, Neonatal Care

    The US Food and Drug Administration (FDA) on Wednesday issued three final guidance documents to aid the development of new drugs for uncomplicated urinary tract infections (uUTI), bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC), and draft guidance to encourage new therapies for newborns.   The final guidances focus on BV, which according to the CDC, is reportedly the most common type of vaginal infection, followed by VVC. The prevalence of uUTI is repo...
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    MHRA Revises Clinical Investigation Guidance in Line With EU MDR

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) revised 2013 medical device clinical investigation guidance to reflect the EU’s medical device regulation (MDR).   Revisions to MHRA’s guidance consider specific MDR changes, which were entered into force in 2017 and have a 26 May 2020 date of application. MDR is set to repeal the EU’s medical device directive (MDD), followed by the in vitro diagnostic regulation’s (IVDR) 26 May 2022 repeal of the IV...
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    First Two-Tiered Algorithm Snags FDA Clearance for Lyme Disease

    The US Food and Drug Administration (FDA) cleared expanded use indications on four Lyme disease test systems that may improve confidence in diagnosing people with the debilitating condition.   The Zeus Borrelia Modified Two-Tiered Testing (MTTT) algorithm eliminates the need for a two-step process in laboratory testing of Lyme disease, reducing the turnaround time for obtaining and interpreting test results. Lyme disease diagnosis has historically involved a protein ...
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    Australia Reacts to Potential Notified Body Shortages

    Australia’s Therapeutic Goods Administration (TGA) on Friday warned of a shortage of notified bodies under the EU’s medical device and in vitro diagnostics regulations (MDR/IVDR) and expanded the scope of what it considers to be acceptable overseas evidence for marketing authorizations.   “TGA is aware of industry concern should a sufficient number of notified bodies not have been designated” by MDR’s 26 May 2020 application. “This may impact manufacturers seeking ce...
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    FDA Finalizes Guidance on Metal Expandable Biliary Stent 510(k)s

    The US Food and Drug Administration (FDA) issued final guidance on Thursday to aid sponsors of metal expandable biliary stents in preparing 510(k) submissions to seek premarket clearance.   The final document supersedes 1998 guidance on the content of 510(k) submissions to FDA for metal expandable biliary stents. It is largely similar to the draft guidance version from July 2018.   FDA’s Center for Devices and Radiological Health (CDRH) seeks to address concerns ...
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    EC Offers Specifications for Reprocessing Single-use Devices Under MDR

     The European Commission (EC) on Tuesday set forth the common specifications (CS) for the reprocessing of single-use medical devices under the EU’s medical device regulation (MDR).   The EC is proposing the CS via a draft implementing regulation to specify requirements for the reprocessing of single-use medical devices in alignment with criteria in Article 17(3) of MDR.   EU member states may choose not to apply rules relevant to manufacturers’ obligations for sing...
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    Allergan Pulls Textured Breast Implant Following FDA Request

    Allergan followed a US Food and Drug Administration (FDA) request to recall its Biocell textured breast implants in response to an increase in breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) cases.   FDA’s Center for Devices and Radiological Health (CDRH) is offering routine updates on an analysis of adverse event reports that describe incidences of BIA-ALCL post-implantation. A Wednesday update on the analysis reports a total of 573 unique BIA-ALCL...
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    Five Deaths Reported Prior to Recall of Intra-aortic Balloon Pumps

    The US Food and Drug Administration (FDA) on Tuesday designated Getinge’s Maquet/Datascope recall of intra-aortic balloon pumps (IABPs) as Class I after five patient deaths were reported since 2016.   The recall seeks to address an issue with the IABPs shutting down during patient use or failing to initiate therapy due to battery failures. Affected modes include all lot numbers of the Cardiosave Hybrid IABPs Cardiosave Rescue IABPs, CS300 IABPs and CS100/100i IABPs. ...
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    FDA Recognizes Standards for Medical Device Interoperability, Safety Assurance Cases

    The latest batch of US Food and Drug Administration-(FDA) recognized consensus standards marked several firsts for the agency, including for interoperability and safety assurance cases.   FDA’s Center for Devices and Radiological Health (CDRH) updated its database of recognized consensus standards earlier this month with 90 new standards, bringing the total up to 1,385 from the last update in January. The database’s new batch includes the first standard for medical dev...