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  • Regulatory NewsRegulatory News

    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...
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    CDRH Discusses Evolution of Q-Submission Program

    Officials at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) offered clarifications related to the Q-submission program’s evolution during a recent webinar. The Q-submission program is intended to provide a mechanism for sponsors of medical device submissions to request early interactions with agency staff prior to reaching the submission phase. A common question to CDRH relates to the newly introduced two-tiered review time...
  • EU MDR Q&A: Bos Discusses a Lack of EU-Wide Portfolio Coordination

    With just about 11 months left before the date of the application of the EU’s medical device regulation (MDR), time has not provided the answers to everything. An EU MDR expert spoke to Focus recently via email about four troublesome areas. Gert Bos, executive director and partner at Qserve consultancy, drew attention to issues that have festered in the MDR transition period—a lack of portfolio coordination, an EU-wide supply bottleneck, notified body (NB) capacity an...
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    FDA and BioCelerate Join Forces on Nonclinical Research

    The US Food and Drug Administration (FDA), under a new collaboration, is poised to explore how to provide better support for early-stage research and development. FDA tapped industry group TransCelerate BioPharma’s subsidiary BioCelerate for the joint working group tasked with exploring methods, tools and/or templates that provide for greater efficiency in the analysis of datasets generated from nonclinical studies. “This collaboration is another step forward as part...
  • Regulatory NewsRegulatory News

    FDA and BioCelerate Join Forces on Nonclinical Research

    The US Food and Drug Administration (FDA), under a new collaboration, is poised to explore how to provide better support for early-stage research and development. FDA tapped industry group TransCelerate BioPharma’s subsidiary BioCelerate for the joint working group tasked with exploring methods, tools and/or templates that provide for greater efficiency in the analysis of datasets generated from nonclinical studies. “This collaboration is another step forward as part...
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    FDA Draft Guidance Seeks to Mitigate Risk of Biotin Interference

    Following a safety communication on an increased risk of adverse events associated with incorrect laboratory test results due to biotin interference, the US Food and Drug Administration (FDA) issued draft guidance on Thursday for testing biotin interference and communicating results with end users. The draft guidance for industry aims to clarify how to test for interference by biotin, also called vitamin B7, on the performance of in vitro diagnostic devices (IVDs) tha...
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    UK NB Will Not Apply for EU MDR/IVDR

    London-based Lloyd's Register Quality Assurance (LRQA) announced Wednesday that it will withdraw from its notified body (NB) services under the EU’s current medical device and in vitro diagnostic directives and will not apply to be an NB under the new medical device and in vitro diagnostic regulations (MDR/IVDR). “Following recent market developments and in the spirit of transparency, we have made the strategic business decision to exit from these services,” said LR...
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    ACell Pays $15M to Resolve Probe Into Failing to Notify FDA of a Market Withdrawal

    The US Department of Justice (DOJ) closed its probe into a devicemaker’s failure to inform the US Food and Drug Administration (FDA) it had withdrawn its powder wound dressing product from the market. ACell pleaded guilty to charges related to its MicroMatrix device and will pay $15 million. The guilty plea charges the Maryland-based devicemaker with one misdemeanor count of failure and refusal to report its 2012 medical device removal, court filings show . A separa...