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    FDA Draft Guidance on Voluntary Recalls Draws Concerns of Inconsistency

    US Food and Drug Administration (FDA) draft guidance on voluntary recalls or product corrections should ensure consistency with current regulations, stakeholders said in recently submitted feedback.   The draft guidance seeks to improve the efficiency and timeliness of voluntary recalls under 21 CFR Part 7 Subpart C, with recommendations on preparations and procedures. Comments submitted to FDA argue consistency is needed across the draft guidance, Part 7 and 21 CFR ...
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    FDA Warns of Cyber Risk With Medtronic Insulin Pumps

    Diabetics using Medtronic’s MiniMed 508 insulin pump and MiniMed Paradigm series should switch to newer models to avoid a potential cybersecurity attack, federal government agencies advised.   A US Food and Drug Administration (FDA) safety communication and a US Department of Homeland Security (DHS) Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) medical advisory  are alerting patients with the models to a cyber vulnerability that could allow a n...
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    Premarket Requirements for Medical Device Cybersecurity Come into Effect in Canada

    Health Canada’s new premarket requirements on medical device cybersecurity came into effect Wednesday, following the adoption of the regulator’s final guidance document earlier this month.   Health Canada fleshed out much of the draft version , issued in December 2018, prior to the 17 June adoption of the final guidance. New requirements seek to improve device cybersecurity by mandating that manufacturers identify and analyze hazards associated with their devices to s...
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    CDRH Finalizes Guidance on Diagnostic Ultrasound Systems and Transducers

    In Wednesday’s final version of US Food and Drug Administration (FDA) guidance on the clearance of diagnostic ultrasound systems and transducers, FDA’s Center for Devices and Radiological Health (CDRH) followed industry requests for greater clarity and addressed legislative updates.   The final guidance is largely similar to the October 2017 draft version . Updates offered clarity in terms of using acoustic output and new uses of approved contrast agents. A new sectio...
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    CDRH Drafts Clinical Recommendations for Prostate Tissue Ablation Devices

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) issued draft guidance Tuesday to support clinical testing of high-intensity ultrasound systems for prostate tissue ablation devices.   The 10-page draft guidance outlines clinical investigation recommendations for the devices and includes benefit-risk determinations in premarket regulatory decisions that are “flexible in some cases” and “tailored to the type and intended use o...
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    IVDs Top the List of Devices Seeing Field Safety Corrective Actions, Report Shows

    More field safety corrective actions (FSCAs) were issued for in vitro diagnostic (IVD) devices than any other device types in the first half of 2019, according to a report published Monday by UK-based MedBoard.   The graphic below shows that IVDs FSCAs totaled 1,251 at the top, followed by cardiology and radiology. The highest number of IVDs FSCAs were reported in Switzerland, the US, Germany, Italy and the UK. Yet IVDs FSCAs were ranked the highest in the European r...
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    Notified Body Survey Offers New Data on EU Medical Device Certificates

    Findings from a recent survey of notified bodies (NBs) for medical devices and in vitro diagnostics (IVDs) indicate fluctuation in the numbers of certificates in 2018 versus prior years.   The European Association for Medical Devices of Notified Bodies—Team-NB—surveyed its 23 members at the end of 2018 and the results illustrate show how companies are preparing for the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR).   Last year saw an increa...
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    EC Previews Call to Set up Expert Panels for EU MDR/IVDR

    The European Commission (EC) said on Friday it will issue a call for applications to set up the expert panels for the premarket product evaluation consultation procedures provided under the EU’s medical device regulation (MDR) and in vitro diagnostic regulation (IVDR).   The EC is preparing to designate the new expert panels that will support the assessments for certain medical device classes and IVDs. The EU legislation obliges the EC to establish the expert panels ...
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    Paclitaxel-Coated Devices’ Late Mortality Signal Not Well Understood, FDA Panel Hears

    Following Wednesday’s debate on missing data necessary for paclitaxel-coated devices’ mortality assessments, the US Food and Drug Administration (FDA) advisory committee on Thursday offered recommendations on how to use what is in place to understand mortality signals.   Limited data on dose effect, toxicity and other potential factors have posed barriers for FDA and industry to achieve a complete understanding of paclitaxel- or drug-coated balloons (DCBs) and paclitaxe...
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    EU MDR/IVDR: MedTech Europe Looks to Tackle Implementation Delays

    MedTech Europe outlined a 7-point plan to aid EU member states in implementing the medical device and in vitro diagnostic regulations’ (MDR/IVDR) new system with greater efficiency and at a faster pace. With the increasing urgency to implement the new regulatory system on time, the 7-point plan serves as a call to action. It covers notified bodies (NBs), product re-certification, Eudamed, guidance, scientific bodies, delegated and implementing acts as well as harmoniz...
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    FDA Panel Faces ‘Conundrum’ with Mortality Assessments on Paclitaxel-Coated Devices

    Discussions at the first day of a two-day US Food and Drug Administration (FDA) advisory committee meeting cited a large amount of missing data and other flaws in conflicting analyses as barriers to finding a mechanism responsible for the increased late mortality rates linked to using paclitaxel-coated balloons (DCBs) and paclitaxel-eluting stents (DESs). FDA officials, experts in the FDA-convened committee and industry agreed that limitations in mortality assessments r...
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    EC Cautions on MDR/IVDR Impact on Device Availability

    In a factsheet posted Monday, the European Commission (EC) acknowledged that the EU’s medical device and in vitro diagnostic regulations (IVDR) “could have consequences for the availability of medical devices for health institutions,” with the potential for some devices to "become temporarily unavailable." The 7-page factsheet highlights the anticipated potential consequences from changes to the risk classifications of devices and IVDs, as well as the wider scope of b...