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    CDRH Talks Up Timeliness of NEST

    Members of the committee governing the National Evaluation System for health Technology Coordinating Center (NESTcc), including US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Director Jeff Shuren, touted the timeliness of NEST in a commentary in Clinical Pharmacology & Therapeutics on Tuesday. Shuren and NESTcc executive director Rachel Fleurence explain how the time for NEST has now come as certain “characteristics of medical ...
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    FDA Warns Integra’s TEI Biosciences Over Contamination Issues

    A TEI Biosciences medical device facility drew an US Food and Drug Administration (FDA) warning letter earlier this month over failures to prevent bacterial contamination of certain manufacturing equipment and products. The warning letter, made public on Tuesday, cites four good manufacturing practice (GMP) violations for the manufacturer of collagen-based medical devices. The first three GMP violations cover a lack of procedures to control environmental conditions as w...
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    CDRH Program Seeks to Resolve 510(k) Issues in New Way

    A quietly-launched pilot at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) was implemented last Monday to evaluate a new approach to resolving issues in 510(k) submissions. “CDRH is implementing the least burdensome flag as a program for 510(k) submissions to act as a performance metric for the implementation of least burdensome requirements,” said Joshua Silverstein, regulatory advisory at CDRH’s Office of Device Evaluation (ODE...
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    EC Details Plan for Eudamed and Medical Device Nomenclature System

    The European Commission (EC) issued long-awaited documents on two essential actions to implement the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR), namely the high-level functional specifications for Eudamed and its final assessment on the future nomenclature for the database. The new documents comply with requirements that the 2017 regulations imposed on the Commission as part of the transitional periods to enter MDR and IVDR into force by 26 May...
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    CDRH Tweaks Guidance on Medical Devices Containing Animal-Derived Materials

    The US Food and Drug Administration (FDA) on Thursday finalized guidance from 2014, with new details on medical devices containing animal-derived materials. The final guidance seeks to aid industry address the risks of human pathogens that could contaminate animal material and thus be present in a medical device that contains contaminated material derived from animal sources. “The role of animal-derived material in medical devices is well established,” FDA’s Center f...
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    Health Canada Begins Release of Clinical Data on Drugs and Devices

    Health Canada launched two public databases on Wednesday as the first step in making clinical information about the safety and effectiveness of drugs and medical devices publicly available. The drug and device databases currently display just one record for each: a notice of compliance issued to CSL Behring Canada in 2016 and an approval granted to Siemens Healthcare GmbH last December. Following consultation on Health Canada’s plans to start making clinical info...
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    CDRH Classifies Respiratory Infection IVD, System for Neurological and Psychiatric Disorders

    The in vitro diagnostic (IVD) device for antibiotic susceptibility testing in respiratory samples and the transcranial magnetic stimulation system for neurological and psychiatric disorders were classified as class II medical devices, following the release of US Food and Drug Administration (FDA) final orders. FDA’s Center for Devices and Radiological Health (CDRH) finalized the class II assignments on the IVD and the system that have been applicable since April and A...
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    Medtronic’s Covidien Agrees to $20M DOJ Settlement Over Kickback Allegations

    Minnesota-based Covidien, now known as Medtronic Minimally Invasive Therapies, agreed to pay nearly $20 million to resolve kickback allegations related to the sales and promotion of its vein ablation products. Under the settlement, Covidien will pay about $17.47 million to the US to resolve the alleged violations of the False Claims Act . It will pay an additional $1.47 million to California and $1.04 million to Florida for claims settled by the states’ Medicaid progra...
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    CDRH’s Phased-In ‘Super Office’ Transformation to Start Next Week

    A phased-in approach to reorganize the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration will begin Monday, with the new “super office” set to transform medical device reviews, oversight and enforcement via integration of a total product lifecycle (TPLC) approach. CDRH Director Jeff Shuren first discussed the reorganization plans in 2017. Certain details, including the overall structure once fully implemented, the name of the new...
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    CDRH Qualifies 3rd Medical Device Development Tool

    A software module intended to aid health care providers in marking and classifying brain contusions became the third medical device development tool (MDDT) to receive US Food and Drug Administration (FDA) qualification. The Traumatic Brain Injury (TBI) Endpoints Development Initiative—supported by a 2014 Department of Defense grant worth $17 million over five years to identify and validate effective TBI endpoints in collaboration with FDA—received FDA qualification on T...
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    Industry Reiterates Concerns on FDA’s Software PreCert Working Model

    The final round of comments on the development of the US Food and Drug Administration’s (FDA) digital health software precertification (PreCert) pilot are in, with some new submissions reiterating concerns facing industry. FDA posted the latest batch of PreCert comments earlier this week and AdvaMed, the American Medical Association (AMA) and GE Healthcare are among those with new submissions. Comments have been submitted since 2017, showing general support for FDA’s Ce...
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    Paige.AI Nabs FDA Breakthrough Device Designation for First AI-driven Cancer Diagnosis

    Startup Paige.AI said Thursday it has received US Food and Drug Administration (FDA) breakthrough device designation for use of its artificial intelligence (AI) in cancer diagnoses.  The move marks the first breakthrough device designation for AI in the diagnosis of cancer. The New York-based startup was just launched early last year based on a license agreement with Memorial Sloan Kettering Cancer Center to create a de-identified digital pathology dataset. The dataset w...