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    FDA Proposes Rule to Implement New De Novo Classification Process

    The US Food and Drug Administration (FDA) issued a proposed rule on Tuesday to establish requirements on the de novo review pathway for classifying new medical device types. If finalized, the rule will implement the de novo classification process and define the scope of regulatory procedures used by agency staff and classification panels convened by FDA when classifying and reclassifying medical devices. The work at FDA’s Center for Devices and Radiological Health (C...
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    CDRH’s Case for Quality Pilot Gains Momentum

    The pilot program led by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) aimed at manufacturing and product quality has gained momentum this year, with dozens of waived post-approval and risk-based inspections among participating firms.   The pilot program is collectively run by CDRH and the FDA-funded public-private partnership Medical Device Innovation Consortium (MDIC) and the CMMI Institute under CDRH’s 2014 Case for Qua...
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    EU Releases Working Plan to Implement MDR/IVDR

    The European Commission (EC) issued a working plan on Wednesday for the implementation of the new EU medical device and in vitro diagnostics regulations (MDR and IVDR). The EC’s working plan describes the legal basis, the expected adoption timelines and the current status of 12 implementing acts under MDR/IVDR and 12 other actions or initiatives. The only implementing act in the roadmap that has been completed so far involves the defined scope of notified body (NB) de...
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    Cybersecurity: FDA Spells Out Updated Premarket Policies

    With its first guidance in the device space in FY 2019, the US Food and Drug Administration (FDA) unveiled an awaited draft guidance on Wednesday to clarify the agency’s cybersecurity expectations from a premarket perspective. The draft guidance is an update to 2014 premarket policies on cybersecurity and came as the ink was still wet on the memorandum of agreement (MOA) between FDA and the US Department of Homeland Security (DHS) for strengthening a coordinated approac...
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    Looking Back at the 2018 Regulatory Convergence: the Newsworthy and Noteworthy

    Attendees of RAPS’ 2018 Regulatory Convergence in Vancouver, 1–4 October, were among the first to learn about important developments and the latest news on topics including the coming EU Medical Device Regulation (MDR), the US Food and Drug Administration’s (FDA) cybersecurity policies and the results of RAPS’ comprehensive global salary survey of regulatory professionals. The event also marked the first time RAPS’ annual gathering has been held in Canada. The confer...
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    CDRH Drafts New Framework to Create a Pediatric Device Safety Network

    A draft framework is in the works at the US Food and Drug Administration (FDA) to create an innovative safety net for pediatric medical devices, Vasum Peiris, Chief Medical Officer for pediatrics and special populations at the Center for Devices and Radiological Health (CDRH), told Focus . The new framework is “centered around the fundamental issue of safety for children,” Peiris said, posing the question “where can we actually innovate safely?” Pediatric academic medic...
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    Cybersecurity: CDRH to Update 2014 Premarket Policies

    Ahead of a new US Food and Drug Administration (FDA) draft guidance set to be released in FY 2019, lead of cybersecurity initiatives at the Center for Devices and Radiological Health (CDRH) Suzanne Schwartz previewed policy changes at RAPS’ 2018 Convergence.   The US healthcare industry has become a target for cyberattacks over the past few years and this has been partly linked to inadequate device designs, which must undergo regulatory premarket reviews to mitigate cy...
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    CDRH Looks to Expand Case for Quality Program

    With plans to establish a full program next year, the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) recently met its goal to complete at least 30 appraisals under the voluntary case for quality (CfQ) pilot program by year’s end. CDRH had already completed a total of 35 appraisals across 18 device companies, as of earlier this month, in collaboration with the Medical Device Innovation Consortium (MDIC) and the CMMI Institut...
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    CDRH Works to Develop Proposed De Novo Regulation

    The regulatory review pathway for novel devices will receive major policy clarifications by mid-2019, program lead at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) said during a forum at RAPS’ 2018 Regulatory Convergence. The de novo program—established about 20 years ago as a mechanism to evaluate devices that are by statute automatically classified into Class III—saw an anomaly in 2017 prior to its first user fees, noted...
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    KPMG/RAPS Survey Digs in to Device Makers' EU MDR Preparedness

    A new report from KPMG and RAPS sheds light on how prepared medical device companies are for the new European medical device regulation (MDR) as the 2020 compliance deadline approaches.   The report, which is based on a survey conducted in June 2018, received responses from more than 200 regulatory and quality professionals at medical device companies worldwide. It was released during RAPS' 2018 Convergence in Vancouver, Canada.    One of the key findings relates t...
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    Brazil’s ANVISA to Eliminate Backlog of Applications

    Brazilian drug regulator ANVISA said Wednesday at RAPS’ Regulatory Convergence that it would eliminate a backlog of new and generic drug applications by January 2019. The elimination of the backlog will free the regulator up for new projects, and comes as more than 800 applications were backlogged as of January 2017, Raphael Sanches Pereira, general manager at ANVISA said. Pereira also said that ANVISA by the end of this year will make a proposal to rely on Certif...
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    Reorganization of OND to Support New Drug Review Modernization, Woodcock Says

    The reorganization of the US Food and Drug Administration’s (FDA) Office of New Drugs will help support the modernization of new drug reviews, Janet Woodcock, head of FDA’s Center for Drug Evaluation and Research told attendees of RAPS’ Regulatory Convergence on Thursday. She said the plan is to begin restructuring the premarket safety review process and then move into the investigational new drug (IND) application process. By frontloading a lot of the activities, th...