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    Device Reporting Requirements for Manufacturers: FDA Finalizes Guidance

    The US Food and Drug Administration (FDA) on Monday finalized guidance to help device manufacturers meet the reporting and recordkeeping requirements for adverse events and malfunctions. The 52-page question-and-answer-based guidance, first drafted in July 2013, supersedes that draft and other guidance from 1997. “The goal is to detect and correct problems in a timely manner,” FDA said on Monday. “This guidance updates FDA’s policy and clarifies FDA’s interpretations ...
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    FDA Finalizes Guidance on Neurological Device Trials

    The US Food and Drug Administration (FDA) on Friday finalized its guidance for sponsors looking to submit an investigational device exemption (IDE) to conduct clinical trials for neurological devices targeting disease progression in diseases such as Alzheimer's and Parkinson's. "FDA believes that neurological devices intended to slow disease progression and improve clinical outcomes that are meaningful to patients may represent a revolutionary option for patients," FDA w...
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    Health Canada Issues New Medical Device Recall Guide

    Health Canada on Thursday issued a new guide on medical device recalls detailing sponsors' responsibilities under the country's Medical Devices Regulations (MDR) , replacing the agency's 2011 guidance . Specifically, the guide provides advice on keeping medical device distribution records, recalling devices, reporting recalls to Health Canada and writing internal procedures related to recalls. The guide has also been rewritten to include callout boxes and additional l...
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    Lead MDUFA Negotiator Details Changes in MDUFA IV Financing

    The US Food and Drug Administration's (FDA) top negotiator for the fourth iteration of the Medical Device User Fee Act (MDUFA IV) presented changes to the funding mechanisms of the program at a public meeting at FDA's White Oak Campus on Wednesday. Last week, FDA released its draft recommendations for changes to its user fee program for medical devices which would allow the agency to collect roughly $999.5 million— an increase of $320 million over the previous five-yea...
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    Asia Regulatory Roundup: CFDA Offers Device Monitoring Guidance (1 November 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia . CFDA Posts Draft Medical Device Adverse Event Monitoring Guidance China’s Food and Drug Administration (CFDA) has posted draft guidance on post-marketing supervision of medical devices. The guidance sets out the role regional and national regulators, medical device manufacturers and adverse event monitoring technology institutions will play in tracking the safety of...
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    FDA Approves First PFO Occluder From St. Jude

    The US Food and Drug Administration (FDA) on Friday approved Minnesota-based St. Jude Medical’s Amplatzer PFO Occluder, which is intended to reduce the risk of a stroke for some patients who previously had a stroke. The device – which was marketed more than a decade ago under a humanitarian device exemption (HDE) but was voluntarily withdrawn by St. Jude in 2006 after FDA concluded that the target population for it was greater than 4,000 patients – is specifically for s...
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    MDUFA IV to add $50-75 Million Annually in new User fee Revenue for FDA

    The US Food and Drug Administration (FDA) on Tuesday proposed increasing user fees for medical device manufacturers by more than $320 million over the next five years, according to a draft proposal for MDUFA IV. The new funding will enable FDA to implement a number of proposed enhancements, with additional funding (amounts will also be adjusted for inflation each year) to be phased in over each fiscal year (FY) as follows: $47,419,400 for FY 2018 $54,849,400 for FY...
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    Asia Regulatory Roundup: CFDA Investigates Trial Sites Over Data Integrity (25 October 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Clinical Data Probe Triggers Investigations Into 11 Trial Sites, CROs China’s Food and Drug Administration (CFDA) has opened investigations into 11 clinical trial sites and contract research organizations (CROs) as part of a data verification drive initiated last year. The regulator suspects the sites and CROs generated fraudulent clinical trial data to support 27 new ...
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    Regulatory Misconduct: FDA Launches Website for Allegations Against Device Manufacturers

    A little more than a week after a scathing report in the Minneapolis Star-Tribune revealed the US Food and Drug Administration (FDA) has accepted late adverse event reports from device companies for hundreds of thousands of incidents, and the agency on Monday launched a new website for regulatory misconduct allegations. The webpage, Allegations of Regulatory Misconduct , allows anyone to submit a claim (via a new, simplified online form ) if it is believed that a me...
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    FDA Targets 15 Hospitals Over Significant Deviations from Medical Device Reporting Regulation

    The US Food and Drug Administration (FDA) on Monday released a summary of hospital inspection findings, as well as Form 483s for 15 hospitals, detailing failures of the hospitals to report medical device-related adverse events. Several high-profile hospitals were included in the list, including Los Angeles-based Cedars-Sinai Medical Center and Boston-based Brigham and Women’s Hospital , for their failure to keep written medical device reporting procedures and to repo...
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    FDA Releases Guidance on Software as a Medical Device for Consultation

    The US Food and Drug Administration (FDA) on Thursday opened a public consultation on a harmonized guidance on the clinical evaluation of software as a medical device (SaMD) developed by the International Medical Device Regulators Forum (IMDRF). Proposed Guidance According to IMDRF, the goal of the guidance is "to establish a common and converged understanding of clinical evaluation and principles for demonstrating the safety, effectiveness and performance of [SaMD]." ...
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    New Report Investigates Use of Analytics to Measure Medical Device Quality

    The Case for Quality, a public-private partnership between the US Food and Drug Administration (FDA) and the Medical Device Innovation Consortium (MDIC), has released a new report on the feasibility and effectiveness of using analytics to measure medical device quality in healthcare decision-making. In order to measure these factors, a Case for Quality working group ran a pilot focusing on knee and defibrillator implants at seven hospitals to determine whether data, both...