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    Swiss Medtech Group Warns of What’s to Come Without Updated EU MRA

    Switzerland’s medical technology lobbying group issued recommendations to manufacturers Thursday to prepare for different possible regulatory scenarios because of uncertainty with the Institutional Agreement between the EU and Switzerland (InstA). Stalling the InstA “directly affects the medical technology sector,” said Swiss Medtech. The group noted challenges with not knowing whether support for the InstA will be voiced and whether Switzerland and the EU’s Mutual Reco...
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    Digital Health: ‘Connecting the Dots’ Across FDA Centers

    The US Food and Drug Administration’s (FDA) creation of a Digital Health Center of Excellence is in the works, although details offered Wednesday did not shed much light on when it’s coming or its envisioned role.   There are “lots of details to be ironed out,” said Bakul Patel, director for digital health at FDA’s Center for Devices and Radiological Health (CDRH), during a session on Wednesday at the AAMI/BSI/FDA International Conference on Medical Device Standards an...
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    FDA Works to Improve Voluntary Recall Processes

    The US Food and Drug Administration (FDA) is looking to establish new guidance on initiating timely voluntary recalls of FDA-regulated products as part of a larger of effort at the agency in the recalls space. FDA issued draft guidance Tuesday on voluntary recalls’ initiation process under 21 CFR part 7 subpart C. “We know that in order for a recall to be effective and timely, it’s crucial that companies be prepared in advance to take all necessary steps for when a r...
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    FDA Proposes Reclassifying Surgical Staplers

    Tens of thousands of surgical staplers for internal use have been associated with serious adverse events, prompting a new proposal from the US Food and Drug Administration (FDA) to reclassify the devices. The reclassification would mean manufacturers of surgical staplers for internal use would face increased requirements as part of the FDA’s Center for Devices and Radiological Health’s (CDRH) new steps to help reduce risks. The agency also issued draft guidance to propo...
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    FDA Approves First Pediatric ADHD Device

    The US Food and Drug Administration (FDA) granted marketing approval to California-based NeuroSigma for the first medical device to be indicated for attention deficit hyperactivity disorder (ADHD) treatment. The decision to authorize marketing of the Monarch external Trigeminal Nerve Stimulation (eTNS) system was reached and announced last Friday, marking the first approved non-drug ADHD treatment. The cellphone-sized Monarch eTNS system was evaluated based on NeuroS...
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    ICT Report Highlights MedTech Positives in USMCA Agreement

    The US International Trade Commission (ICT) issued a new report on the likely impacts of the US-Mexico-Canada Agreement (USMCA) on the US economy and specific industry sectors—which include medical devices and technologies, pharmaceuticals and biotechnologies. USMCA has received mixed reactions since the agreement between the US, Mexico and Canada was signed last November. Device industry group AdvaMed was quick to welcome the latest report, while the generic drug indus...
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    FDA Approves First Generic Naloxone Nasal Spray for Opioid Overdose Treatment

    Teva Pharmaceuticals USA snagged US Food and Drug Administration (FDA) final approval for the first generic naloxone hydrochloride nasal spray known as Narcan, the agency announced on Friday. The life-saving medication is indicated for stopping or reversing the effects of an opioid overdose and the approval forms part of the agency’s ongoing efforts to combat the nation’s opioid crisis. Generic injectable naloxone products are already in use at health care settings, but...
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    Experts Seek Alignment of Standards Recognition Across FDA’s CDER, CBER, CDRH

    In comments to US Food and Drug Administration (FDA) February draft guidance, industry experts called on the agency for alignment of the approaches to voluntary consensus standards (VCS) recognition. The comment period for feedback on the VCS program FDA’s Center for Drug Evaluation and Research (CDER) proposed via its February draft guidance closed earlier this week, with submissions from several standards development organizations (SDOs) and others. SDOs, in general...
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    CDRH Draft Guidance Tackles Nitinol Devices

    As part of a broader effort to address potential safety issues from materials in medical devices, the US Food and Drug Administration (FDA) proposed technical considerations for nitinol-containing devices. The draft guidance FDA’s Center for Devices and Radiological Health (CDRH) issued on Thursday covers the types of information to include in premarket submissions of devices made from nitinol, including material composition and manufacturing parameters, pseudoelasticit...
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    CDRH Drafts Guidance on Quantitative Imaging

    Manufacturers looking for premarket submission recommendations for medical devices that generate quantitative imaging values have a new resource as the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released draft guidance Thursday. CDRH’s proposed recommendations cover the device’s functional description, technical performance assessment and labeling/user information. For devices that include quantitative imaging functions, th...
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    MedTech Europe Warns Over ‘Untenable’ Transition to EU MDR/IVDR

    MedTech Europe sent an open letter to the European Commission (EC) on Monday to urge immediate action on implementing the new medical device and IVD regulations as the transition is becoming “clearly untenable.” The letter from the trade association’s CEO Serge Bernasconi underscores the growing urgency and need for the EC and member states to finish what they started in 2017 with the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR). The letter highl...
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    WHO Releases First Guideline on Digital Health Interventions

    The World Health Organization (WHO) on Wednesday released a first-of-its-kind guideline on 10 ways for countries to apply digital health interventions across the health system while avoiding potential detrimental effects. The 10 recommendations are detailed in the UN agency’s 124-page guideline for strengthening health systems through the appropriate implementation of digital health. The focus of the guideline is currently limited to digital health technologies that can...