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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...
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    France Drafts Medical Device Cybersecurity Recommendations

    France’s National Agency for the Safety of Medicines and Health Products (ANSM) has developed draft recommendations on the cybersecurity of medical devices.   ANSM developed the draft recommendations to help minimize the risk of a cyberattack in medical devices integrating software (MDIS) in early development and throughout the total product lifecycle (TPLC). Its guideline will implement best practices and appropriate standards to address the inconsistent culture of cy...
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    Medical Device Premarket Cybersecurity: TGA Finalizes Guidance

    The premarket requirements on medical device cybersecurity from Australia’s Therapeutic Goods Administration (TGA) came into effect on Thursday, with new details that further underscore the agency’s push for the total product lifecycle (TPLC) approach and international harmonization.   A 53-page final guidance sets the premarket cybersecurity requirements on manufacturers and sponsors of medical devices and in vitro diagnostic devices. Requirements are centered on es...
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    FDA Validates Streamlined Review of SaMD Under PreCert Pilot

    In a Thursday update on the US Food and Drug Administration’s (FDA) Precertification (PreCert) pilot program for software as a medical device (SaMD), the Center for Devices and Radiological Health (CDRH) said retrospective testing supported the streamlined review of SaMD.   CDRH’s PreCert team retrospectively tested previously reviewed submissions in May to see if the accelerated review pathway tailored to SaMD products provides the same level of reasonable assurance o...
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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...