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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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    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...
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    FDA to Further Investigate Implantable Devices Containing Certain Metals

    Following concerns and reported adverse events linking biological responses to certain types of materials in medical devices, the US Food and Drug Administration (FDA) said recently that it will further engage stakeholders to investigate metal-containing implants and dental amalgam. Part of that engagement will involve a public advisory committee meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee on 13-14 November, which will discuss the...
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    Patient Engagement in Device Trials: FDA Drafts Guidance

    The US Food and Drug Administration (FDA) on Monday released new draft guidance explaining how sponsors can improve the design and conduct of medical device clinical investigations by using patient experience, perspectives and other relevant information. The 10-page draft mainly addresses four questions: What approaches might sponsors use to engage patient advisors (defined by FDA as those who have dealt with or are dealing with a particular condition but are not inv...
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    First MDR Certificate Issued for Class III Device

    Notified body TÜV SÜD announced Thursday that it has issued the first Medical Devices Regulation (MDR) certificate for one of Germany-based Biotronik’s Class III (highest-risk category) medical devices, in addition to its quality management system. The newly certified device is Biotronik’s Renamic programmer software , which enables physicians to program and test implanted cardiac devices such as pacemakers, implantable cardioverter-defibrillators and cardiac resynchro...
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    EC Adds IMQ as Fourth Notified Body Designated Under MDR

    The European Commission (EC) on Tuesday added Milan, Italy-based IMQ Istituto to its list of notified bodies (NBs) designated under the new Medical Devices Regulation (MDR). The announcement does not come as a surprise, as Italy’s Ministry of Health announced in late July that IMQ met the requirements of the regulation. The EC had also previously indicated in its rolling plan,  updated last Monday , that four NBs have been designated. The other three NBs to be de...
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    Edwards Lifesciences Recalls Devices After 3 Deaths Reported

    The US Food and Drug Administration (FDA) recently announced a Class I recall of more than 700 Edwards Lifesciences’ IntraClude Intra-Aortic Occlusion Devices after receiving 22 complaints related to balloon rupture or puncture, including three deaths. The device is used in patients undergoing cardiopulmonary bypass — a technique described by FDA as when “a machine temporarily takes over the function of the heart and lungs during surgery. When the IntraClude balloon is ...
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    Concussion Assessments: FDA Warns Against Using Unapproved Devices

    The US Food and Drug Administration (FDA) on Wednesday warned against using a smartphone- or tablet-based app to assess whether an injured or possibly concussed person is suffering from a change in physical or mental status including vision, concentration, memory, balance and speech. After identifying several manufacturers marketing devices for concussion diagnosis, treatment or management without FDA’s approval or clearance, the agency said it issued a safety communica...