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    FDA Warns of Battery Depletion in Medtronic Pacemakers

    Manufacturing defects continue to cause distress for Medtronic, with a new US Food and Drug Administration (FDA) safety communication warning of premature battery depletion in pacemakers. The agency’s safety notice alerted about an issue with device capacitors, which led to rapid battery depletion in certain Medtronic implantable pacemaker models. It indicated FDA’s awareness of three adverse event reports linked to this issue—one of which resulted in the death. “In ...
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    Experts Raise Concerns with FDA Draft Guidance on Combo Product Reviews

    US Food and Drug Administration (FDA) draft guidance on combination products’ premarket review principles needs further clarity on a range of issues, according to commenters. The public comment period on the February draft guidance —a document tasked with implementing goals set forth under section 3038 of the 21 st Century Cures Act of 2016 —closed earlier this week. Commenters show appreciation for FDA’s efforts to serve such goals of greater “clarity, predictab...
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    Industry Works to Circumvent EU MDR/IVDR ‘Horror Story’

    Transitioning to the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR) have left industry with no choice but to resort to contingency planning, including an IVDR “plan B.” From the looming shortfall of notified bodies (NBs) to the ongoing lack of MDR/IVDR guidance, 2019 FDA/Xavier MedCon conference sessions underscored daunting realities related to the regulatory overhaul. NBs, manufacturers and regulatory authorities have come increasingly under pres...
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    CDRH Remains Bullish on 510(k) Modernization

    At the 2019 FDA/Xavier MedCon conference in Cincinnati this week, modernizing the 510(k) program at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) was called into question because of limited industry use of the new or expanded 510(k) programs. But CDRH officials remained steadfast in their plans. Industry struggled to keep pace with the rapidly evolving 510(k) landscape, with 510(k) modernization initiatives launched in the pas...
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    FDA’s Device Inspections Program Sets FY19 Performance Goals

    New performance goals for the Office of Medical Device and Radiological Health Operations (OMDRHO) at the US Food and Drug Administration (FDA) were set on FDA’s and industry’s follow-up to inspections. The performance goals for fiscal year (FY) 2019 are intended to tell the story behind inspection metrics in terms of the public health impact, OMDRHO Director Jan Welch said at the 2019 FDA/Xavier MedCon conference in Cincinnati. Welch, who took the helm at OMDRHO with t...
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    CDRH Launches ‘Super Office’

    The new Office of Product Evaluation and Quality (OPEQ) at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) officially launched on Wednesday, CDRH Director Jeffrey Shuren announced at the 2019 FDA/Xavier MedCon conference in Cincinnati. OPEQ—deemed by CDRH as the “super office”—internally puts into practice the total product lifecycle approach (TPLC) to regulatory decision-making in premarket reviews, postmarket surveillance ...
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    Texas Firm Draws FDA Warning Over Adulterated Device

    In a new US Food and Drug Administration (FDA) warning letter, Plano, TX-based Surgisil was urged to come into compliance with the marketing of its Perma Facial Implant over an unapproved intended use. FDA conducted an inspection of Surgisil’s operations, including its website , last September and determined the firm had been marketing the Perma Facial Implant for augmentation of the lips. The device obtained 510(k) clearance for “cosmetic augmentation and correction...
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    FDA Flags Incidents of Excess Radiation Exposure to Patients

    The US Food and Drug Administration (FDA) imposed a boxed warning on the labeling of rubidium 82 generators, which are used with Positron Emission Tomography (PET) heart perfusion imaging scans. The agency circulated the drug safety alert on Monday in response to recent excess radiation exposure incidents. Manufacturers Bracco Diagnostics and Jubilant DraxImage also sent letters last month to inform health care providers about incidents of patients’ exposure to high lev...
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    WHO Details Plan to Combat Antimicrobial Resistance Globally

    The World Health Organization (WHO) finalized a report on combating antimicrobial resistance (AMR), stressing the urgency to act. The final report—developed by the Interagency Coordination Group on Antimicrobial Resistance (IACG)—identifies 14 recommendations centered on the urgency and action needed for a global fight against AMR. “The challenges of antimicrobial resistance are complex and multifaceted, but they are not insurmountable,” WHO said, arguing the report’...
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    Scope of FDA Draft Guidance on Nonbinding Feedback is Too Restrictive, Industry Argues

    US Food and Drug Administration (FDA) draft guidance drew criticism from industry because of certain deadlines related to Form 483 nonbinding feedback. The February draft guidance proposes a standardized method to request FDA feedback on remediation actions for 483 citations without holding a medical device establishment to a promise after an inspection. Yet the draft guidance waters down the method’s utility, comments made public earlier this week argue. The pu...
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    FDA Finalizes Guidance on Convenience Kit UDI Marking

    The US Food and Drug Administration (FDA) issued final guidance Thursday to provide medical device manufacturers clarifications on unique device identification (UDI) marking policies for convenience kits. The guidance finalized the 2016 draft version of the document, developed by FDA’s Center for Devices and Radiological Health and its Center for Biologics Evaluation and Research. Combination products and in vitro diagnostics subject to labeling requirements fall ou...
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    IMDRF Takes Another Stab at IVDs, MDSAP

    Medical device regulators launched new initiatives on harmonizing in vitro diagnostic (IVD) regulations and tweaking the Medical Device Single Review Program (MDSAP) for additional countries to participate. A new working group (WG) was established to take up new work on IVDs and was approved at the last International Medical Device Regulators Forum (IMDRF) management committee meeting in Russia in March. A new category for interested countries to participate in MDSAP ...