• Regulatory NewsRegulatory News

    FDA creates umbrella emergency pathway for COVID-19 serology tests

    The US Food and Drug Administration (FDA) has created a new pathway to support the emergency authorization of tests for antibodies of the virus that causes COVID-19.   Serology tests could play an important role in the safe lifting of lockdowns by enabling authorities to identify individuals with antibodies of the SARS-CoV-2 virus and calculate what proportion of a population has already been infected. The pathway unveiled by FDA on Wednesday gives test developers a ne...
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    FDA lifts requirements for fever screening devices

    Telethermographic devices originally intended for industrial, construction and commercial use can be repurposed to assist in initial screening for fever and triage of individuals in high traffic areas such as airports and businesses under guidance issued by the US Food and Drug Administration (FDA). The guidance was issued for the duration of the public health emergency related to coronavirus disease (COVID-19). “The guidance may help address urgent public health con...
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    FDA eases entry for psychiatry apps during COVID-19 crisis

    To address mental health needs during the coronavirus disease (COVID-19) public health emergency, the US Food and Drug Administration (FDA) today announced it would relax certain premarket requirements for computer programs and mobile apps designed to support treatment of conditions such as depression, anxiety, obsessive compulsive disorder and insomnia. The guidance addresses Class II prescription-only devices and computer programs that support clinician-supervised out...
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    FDA grants first EUA for blood purification device for COVID-19 patients

    The US Food and Drug Administration (FDA) on Friday granted its first emergency use authorization (EUA) for a blood purification system to treat patients at risk for respiratory failure due to coronavirus disease (COVID-19).   The EUA was granted to Terumo BCT Inc. and Marker Therapeutics authorizing the use of their Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices to filter cytokines and other inflammatory proteins from patients’ blood.  ...
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    FDA issues 2nd EUA for decontamination system for N95 masks

    The US Food and Drug Administration on Friday issued a second emergency use authorization (EUA) to help decontaminate N95 or N95-equivalent respirator masks so they can be reused by health care workers in hospitals. FDA said this EUA, issued to Steris Corporation for a system that uses vaporized hydrogen peroxide, will support the decontamination of about 750,000 N95 respirators per day in the US. The EUA comes as shortages of the masks have pushed some hospitals to...
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    MDCG explains when devices can be exempt from premarket clinical consultations

    The Medical Device Coordination Group (MDCG) recently updated its guidance on interpreting Article 54(2)b of the Medical Devices Regulation (MDR), which discusses the criteria that exempt devices from the premarket clinical evaluation consultation procedure with expert panels. According to the text of the article, the clinical evaluation consultation procedure shall not been required when: (a) a firm is renewing certificate under MDR; (b) a device “has been design...
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    Notified body audits during the pandemic: New MDCG guidance

    The Medical Device Coordination Group (MDCG) on Wednesday issued guidance to help notified bodies perform audits during the pandemic, including, under certain circumstances, remote audits. The 5-page guidance deals strictly with surveillance audits under the medical devices directives, audits conducted for recertification purposes under the directives, in cases where a manufacturer submits a change notification to a notified body that would typically require an on-site ...
  • 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...
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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, ...