• Feature ArticlesFeature Articles

    Eudamed’s delay and its impact on clinical investigations under the EU MDR

    This article reviews possible ramifications caused by the delay in launching the European Union’s new electronic database, the European Database on Medical Devices (Eudamed).The author discusses potential issues when clinical investigation data is not transparent or accessible. Until Eudamed is available, posting study results on other databases is recommended so manufacturers can meet requirements for clinical investigation transparency and disclosure while sharing clinic...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News

    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, ...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...