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    MDSAP Changes Aim to Reduce Audit Times

    With an eye on a 1 January 2019 deadline for transitioning to only Medical Device Single Audit Program (MDSAP) quality management system certificates accepted for medical device license applications by Health Canada, the MDSAP consortium has implemented a couple of changes to speed up audits. The changes follow comments received by Health Canada from Canadian medical device license holders regarding the current audit-time model for MDSAP and subsequent annual survei...
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    De Novo Classifications: FDA Drafts Guidance on Acceptance Reviews, Finalizes Guidance From 2014

    Following the creation of a new De Novo classification request user fee under the fourth iteration of the Medical Device User Fee Amendments (MDUFA IV) of $93,017 (small businesses pay $23,254), the US Food and Drug Administration (FDA) on Friday released one final guidance and one draft guidance. The draft and final guidance come as FDA has seen an increased De Novo submission volume, from 42 submissions in 2014 to 69 in 2017. The draft guidance, when finalized...
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    FDA Finalizes Two Guidances on Sharing Device Data With Patients, Aspirator Device Labeling

    The US Food and Drug Administration (FDA) on Friday finalized two guidance documents, including one related to medical device manufacturers sharing information with patients upon request, and another to recommend the addition of a specific safety statement to the product labeling of certain ultrasonic surgical aspirator devices. Sharing Patient Info The five-page guidance, first released as a draft in June 2016 , is meant to convey FDA's position on manufacturers ...
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    First Implementing Act Under EU MDR, IVDR Open for Consultation

    The first implementing act for the EU’s new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) is open for comments until next Wednesday. Implementing acts allow the commission to tease out the intricacies of the legislation and this first one is related to the Notified Body product codes for medical devices and IVDs. The codes, included in the implementing regulation's annexes, are used to categorize the fields of expertise of the NBs ...
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    Health Canada Seeks to Update User Fees for Drug and Device Firms

    Health Canada this week opened for consultation a proposal to update and increase some of the fees it assesses for pharmaceutical and medical device companies, noting that the last update came in 2011 and was based on 2007 data. In addition to increasing some fees significantly (see more below on some of the changes), the proposal would also give new authority to Health Canada to withdraw or withhold service or approval if a fee is not paid, and all fees moving fo...
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    IMDRF Consults on Use of Registries to Support Device Approval Decisions

    The International Medical Device Regulators Forum (IMDRF) has opened for consultation until 1 December a third document on examining the use of registries to support medical device regulatory decision making. Background Registries, which can capture outcomes associated with medical device use, were identified by IMDRF in 2014 as having "a significant gap" in optimal use for regulatory decision making. This gap led to the creation of IMDRF Registry Working Group ...
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    FDA Releases 5 Medical Device Guidance Documents

    The US Food and Drug Administration (FDA) on Friday released a draft guidance document on recommendations for submitting 510(k)s to market ultrasound devices, final guidance in the form of a Q&A on the CDRH appeals process, final guidance on developing and responding to deficiencies, final guidance on display devices for diagnostic radiology and draft guidance on the classification and requirements for laser illuminated projectors. Ultrasounds The 60-page draft gui...
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    CDRH Plots Creation of New 'Super Office,' Alternative 510(k) Pathway

    Jeff Shuren, director of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) told attendees at the final session at AdvaMed’s MedTech conference in San Jose, California, that his center is plotting the creation of a new "super office." The so-called "Total Product Life Cycle 'Super' Office" will integrate premarket, postmarket surveillance and quality-compliance functions, Shuren said, noting it will be "a big deal." The o...
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    MDSAP Update: Canada's 2019 Deadline Still on Track

    Speaking at RAPS' 2017 Convergence on Monday, officials from two international regulators and representatives from auditing organizations offered the latest on the Medical Device Single Audit Program (MDSAP). Background MDSAP is an effort by regulators in the Australia, Brazil, Canada, Japan and the US to establish a single audit process, conducted by recognized third-party auditors, that can meet the requirements of regulators in each country. For manufacturers, MDSAP ...
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    CDRH Releases 8 Warning Letters for Foreign, US Device Manufacturers

    About a week after the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) was criticized for sending a historically low number of warning letters so far in 2017, a flood of new letters were released Wednesday. The warning letters were sent from February through August 2017 to three manufacturers from the US, and five  in Brazil, the Netherlands, Germany, China and Bulgaria. The release of the letters follows a story in Bloo...
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    Procedures for Device Advisory Committee Meetings: FDA Finalizes Guidance

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday finalized guidance from 2015 on advisory committee meetings. Background Other than the Medical Devices Dispute Resolution Panel (which this guidance does not address), there are 17 device panels: (1) Anesthesiology and Respiratory Therapy Devices; (2) Circulatory System Devices; (3) Clinical Chemistry and Clinical Toxicology Devices; (4) Dental Products; (5) E...
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    European Regulatory Roundup: Industry Seeks Post-Brexit System Prioritizing Ties to EMA (31 August 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Industry Asks UK Government for Post-Brexit System That Prioritizes Ties to EMA Over Flexibility The United Kingdom life sciences industry has asked the government to prioritize maintaining close ties to regulators in Europe as it shapes the post-Brexit landscape. Offered the choice between seizing potential regulatory flexibilities created by splitting from the Euro...