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    FDA, EMA Advise on Risk-Based Monitoring in Clinical Trials

    US and EU officials explained on Wednesday what their respective regulatory agencies look for in clinical trial risk-based monitoring (RBM) and how RBM can impact review times.   Under a cooperative agreement with the US Food and Drug Administration (FDA), the Duke-Margolis Health Policy Center convened the public workshop in Washington, DC for a debate on improving the implementation of RBM in clinical trials by identifying how regulators can help with some of the cur...
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    CDRH Instructs on Magnetic Field Interference with Shunt Systems

    Magnetic externally programmable cerebrospinal fluid (CSF) shunt valve settings can inadvertently change when at a distance of fewer than two inches from common magnetic sources such as cell phones, a US Food and Drug Administration (FDA) analysis concludes.   FDA’s Center for Devices and Radiological Health (CDRH) reports that exposure to strong magnetic fields from either external magnetic sources or magnet-containing hearing devices like cochlear implants could resu...
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    FDA Proposal to Pull Some Radiological Health Regulations Draws Mixed Reactions

    A US Food and Drug Administration (FDA) proposal to amend and repeal parts of its radiological health regulations will enable better use of resources and reduce duplication, but clarifications are needed on the recording and reporting requirements, stakeholders argue.   The comment period on the March proposed rule closed earlier this month, with letters from industry groups AdvaMed and the Medical Imaging & Technology Alliance (MITA), as well as medical organization...
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    FDA Looks for New Device Sterilization Methods

    Following the closures of contract sterilization facilities that prompted the US Food and Drug Administration (FDA) to alert to the potential for medical device shortages, the agency launched two public innovation challenges Monday to spur sterilization alternatives and reduce emissions.   The first innovation challenge is intended to identify methods or technologies as alternatives to ethylene oxide (EtO) sterilization, while the second innovation challenge will look ...
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    IMDRF Opens Consultation on Annex Related to Adverse Event Terminology

    The International Medical Device Regulators Forum (IMDRF) proposed a new annex to its adverse event terminology technical document to include medical device parts and components.   Annex G proposes the terminology on medical device parts and components using the same Excel spreadsheet format as Annexes A through F. The proposed document seeks to harmonize definitions for a range of parts, including materials, and components including accessories.   “The terms allow...
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    First FDA-Developed Medical Device Development Tool Receives Qualification

    A tissue mimicking material (TMM) for use in the preclinical development and evaluation of ultrasound medical devices became the first medical device development tool (MDDT) developed by the US Food and Drug Administration (FDA) to receive FDA qualification.   Device developers can use this MDDT to help test the safety of their high-intensity therapeutics ultrasounds (HITU) devices before moving to clinical trials.   With the TMM’s qualification, the MDDT program n...
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    Why Industry Anticipates a ‘Cliff-Edge’ Scenario With EU MDR/IVDR

    The EU’s medical device and in vitro diagnostic regulations (MDR/IVDR) may cause a “cliff-edge scenario,” meaning a disruption in the supply of certain medical devices and IVDs, industry groups and the European Commission (EC) recently cautioned.   Experts see the potential for such disruptions because of roadblocks in transitioning to the new regulatory framework, including notified body (NB) designation delays. And although these issues have come under the spotligh...
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    EC Issues Additional Guidance on Device Vigilance System

    While highlighting an updated version of the manufacturer incident report (MIR) form that will become mandatory in January 2020, the European Commission (EC) issued guidance Tuesday on the medical device vigilance system under the EU’s medical device directive.   The January version of the MIR introduces the use of the adverse event terminology/coding harmonized via the International Medical Device Regulators Forum (IMDRF) and the use of unique device identification (U...
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    Live Case Presentations of Investigational Devices: FDA Finalizes Guidance

    The final guidance issued on Wednesday establishes new recommendations and considerations for a live or pre-recorded broadcast of a surgical or percutaneous procedure under an investigational device exemption (IDE).   The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) provides recommendations with regard to human subject protection measures and what to include in an IDE application for sponsors seeking to conduct these broadca...
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    AdvaMed Calls for Tweaks to FDA Draft Guidance on Inspections

    In two comments submitted to US Food and Drug Administration (FDA) draft guidance on inspections of medical device establishments, AdvaMed recommended several changes.   The draft guidance, issued in March, seeks to make the processes and standards for FDA inspections of device establishments uniform, per the criteria set forth under the FDA Reauthorization Act of 2017 (FDARA). Yet AdvaMed argues the draft guidance fails to deliver.   “The current wording of th...
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    EU MDR/IVDR: EC Calls for Observers to Sit on Nomenclature Subgroup

    The European Commission (EC) issued a call for applications to serve on a subgroup that will assist and advise on nomenclature-related issues, including unique device identification (UDI) and surveillance, as part of the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR).   The 5 July call gives industry associations and other health professionals or stakeholders until 5 August to submit applications. The EC’s Directorate-General for Internal Market, ...
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    WHO Updates Lists of Essential Medicines, Diagnostics

    The World Health Organization (WHO) on Tuesday released the latest lists of essential medicines and essential in vitro diagnostic (IVD) tests, which can help countries prioritize critical health products.   The updated essential medicines list (EML) adds 51 new medicines, bringing the total to 460 medicines. The updated essential diagnostics list (EDL) adds 115 tests to the 113 tests in the first EDL version , published last May.   The focus of the EML is medici...