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    FDA offers expanded use for ECMO, cardiopulmonary bypass and ophthalmic devices amid COVID-19

    The US Food and Drug Administration (FDA) on Monday issued guidance allowing for limited expanded use of extracorporeal membrane oxygenation (ECMO) and cardiopulmonary bypass devices during the coronavirus disease (COVID-19) pandemic.   The agency also opened the door to expanded use for a range of ophthalmic assessment and monitoring devices to reduce the need for in-person visits to health care facilities during the outbreak.   ECMO and Cardiopulmonary Bypass Devi...
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    FDA relaxes rules for infusion pumps, clinical thermometers

    Adding to a growing list of medical devices with eased regulatory requirements amid the coronavirus disease (COVID-19) pandemic, the US Food and Drug Administration (FDA) over the weekend released new guidances for infusion pumps and clinical thermometers in an effort to increase availability of the devices.   The two guidelines, which take effect immediately, follow similar guidelines released in recent weeks covering diagnostic tests , ventilators , surgical appar...
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    3M questions Trump order to halt respirator exports

    The Trump Administration on Thursday formally invoked the Defense Production Act (DPA) to require 3M to prioritize orders from the Federal Emergency Management Agency for N95 respirator masks and requested that the firm cease exporting respirators to Canada and Latin America. Trump tweeted late Thursday: “We hit 3M hard today after seeing what they were doing with their Masks. ‘P Act’ all the way. Big surprise to many in government as to what they were doing - will ...
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    European Commission proposes to delay MDR by a year due to COVID-19

    The European Commission on Friday released a proposal that would defer for a year the Medical Devices Regulation (MDR) from taking effect on 26 May. The European Parliament is expected to vote on the proposal on 16 April. With an eye toward avoiding the disruption of the device market at such a critical time, the year-long delay will not alter the substance of MDR. The delay also will “not impose new obligations on the concerned parties. It primarily aims at providing, ...
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    CDRH warns 5 device firms in US, China, Hungary, Thailand and Taiwan

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) recently released five warning letters sent to medical device manufacturers around the globe due to various violations. The release comes as device warning letters plunged nearly 90% over five years and as CDRH only issued nine warning letters in all of 2019. US For Nevada-based Steiner Biotechnology, an investigator from FDA’s Office of Bioresearch Monitoring Operation...
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    Clinical trials during COVID-19: Updates from FDA, MHRA and TGA

    The US Food and Drug Administration (FDA) last week updated its guidance from earlier this month on conducting clinical trials during the coronavirus disease (COVID-19) pandemic.   The update comes as other regulatory authorities offer updates on managing new or ongoing clinical trials during the outbreak and as pharma companies have begun to halt or alter ongoing trials. Both European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulator...
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    Eudamed to Launch in 2022 for Both Devices and IVDs

    The European Commission recently concluded that its database of medical device information (Eudamed) will only be operational once all modules are fully functional and an independent audit has been conducted, so the commission has decided to launch the database simultaneously for both medical devices and in-vitro diagnostics together in May 2022. The two-year delay of the database for medical devices (the commission reiterated that date of application of the Medical Dev...
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    Safeguarding the US Pharmaceutical Supply: Woodcock Discusses Challenges, Shift Overseas

    As drug and active pharmaceutical ingredient (API) manufacturing moves overseas to cut costs, quality and reliability concerns have been raised and the House Energy & Commerce Committee’s Subcommittee on Health met Wednesday to discuss the supply chain with one of the US Food and Drug Administration’s top officials and other experts. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, explained how part of the problem is that FDA does not know the...
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    FDA Floats Idea of a Rating System for Drug Manufacturers

    The US Food and Drug Administration’s (FDA) Task Force on Drug Shortages supports the idea of creating a new rating system to help drug purchasers, including consumers, better understand the quality management of drug manufacturing facilities. “This idea envisions that pharmaceutical companies could, at their discretion, disclose the rating of the facilities where their drugs are manufactured,” Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, w...
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    Submitting Manufacturing Facility Information: Final FDA Guidance

    The US Food and Drug Administration (FDA) on Tuesday finalized a question and answer guidance on the type of manufacturing facility information that should be included in applications submitted to the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. FDA explains that the guidance is meant to help companies understand how not to submit extraneous information or misplaced or missing information that could result in delays, Refu...
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    PIC/S Opens Consultations on Manufacturing ATMPs, Biological Medicinal Substances

    The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is seeking comments on revisions to two parts of its GMP Guide (Annex 2A and Annex 2B) that deal with the manufacture of advanced therapy medicinal products (ATMPs) and biological medicinal substances and products for human use. PIC/S explains that draft Annex 2A accounts for international developments in the regulation of ATMPs, with particular attention to the European Commission guideline on GMP for ATMPs, whi...
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    FDA Warns of Widespread Device Cyber Vulnerabilities

    Following other regulators’ warnings, the US Food and Drug Administration (FDA) on Tuesday alerted medical device manufacturers and other stakeholders to 11 vulnerabilities that may allow for remote control of a range of medical devices and changes to their functions that may prevent a device from functioning properly. The Cybersecurity and Infrastructure Security Agency within the US Department of Homeland Security also released an  advisory  in July about the cybersec...