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  • Regulatory NewsRegulatory News

    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    Scope of FDA Draft Guidance on Nonbinding Feedback is Too Restrictive, Industry Argues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 ...
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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...