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  • Regulatory NewsRegulatory News

    FDA warns bronchoscope manufacturer for complaint handling, validation issues

    The manufacturer of a rigid bronchoscope system received a warning letter last month from the US Food and Drug Administration (FDA) for lack of adequate evaluation of complaints that components of the system separated during procedures, together with other deficiencies.   Massachusetts-based Lymol Medical Corporation (Lymol) manufactures the Medical Elite X Class Rigid Bronchoscope System and the Lymol Medical Optical Telescope. The FDA warning letter of 7 April 2020...
  • RoundupsRoundups

    Asia Regulatory Roundup: TGA orders re-evaluation of COVID-19 antibody studies amid false negative concerns

    Australia’s Therapeutic Goods Administration (TGA) has asked the sponsors of point-of-care tests for antibodies against the SARS-CoV-2 coronavirus to re-evaluate their clinical performance studies. TGA made the request after reviewing the findings of a postmarket evaluation carried out by a third party.   The Onsite and VivaDiag tests, which are made by CTK Biotech and VivaChek Biotech, respectively, came to market with instructions for use that quoted sensitivity figu...
  • Regulatory NewsRegulatory News

    Swedish notified body is 14th designated under MDR

    Sweden’s Intertek Medical Notified Body AB on Friday became the 14 th notified body designated under the EU Medical Devices Regulation (MDR).   The newly designated notified body is the fifth to be designated in 2020, following the designation of German notified body mdc medical device certification GmbH last month, and the first to be designated in Sweden. (RELATED: German notified body is 13th designated under MDR as MHRA plots delay guidance , Regulatory Focu...
  • Regulatory NewsRegulatory News

    EC sets timeline for rolling out Eudamed modules

    The European Commission will begin making some Eudamed modules available next year, including the actor registration module originally anticipated this month, according to an email to members of the Eudamed working groups.   The message was circulated after the one-year delay of the Medical Devices Regulation (MDR) was adopted by the European Council in late April and follows the Commission’s decision to delay the application of Eudamed by two years to May 2022. (REL...
  • Regulatory NewsRegulatory News

    MDCG offers guidance on safety reporting for device studies under MDR

    The European Commission’s Medical Device Coordination Group (MDCG) on Wednesday released a new guidance explaining how safety reporting in clinical investigations of medical devices should be performed under the Medical Devices Regulation (MDR).   The guidance comes after both the date of application of the MDR and the launch of Eudamed were delayed by one and two years, respectively. (RELATED: MDR delay official as industry calls to push back IVDR , Regulatory F...
  • Regulatory NewsRegulatory News

    FDA updates guidance on clinical trials amid COVID-19

    The US Food and Drug Administration (FDA) this week updated its guidance on conducting clinical trials amid the coronavirus disease (COVID-19) pandemic to address new questions, including the use of alternate laboratory or imaging centers, video conferencing and postmarketing requirements.   The update also features clarifications to questions addressed in previous versions of the guidance on managing protocol deviations and amendments and on steps sponsors should take...
  • Regulatory NewsRegulatory News

    FDA authorizes first antigen test for COVID-19, updates EUA templates

    After issuing an emergency use authorization (EUA) for the first antigen test for coronavirus disease (COVID-19) over the weekend, the US Food and Drug Administration (FDA) on Monday updated its EUA templates for molecular diagnostics and posted a new EUA template for antigen test developers.   On Saturday, FDA announced it had issued an EUA to Quidel Corporation for its Sofia 2 SARS Antigen FIA test to detect SARS-CoV-2 antigens from nasopharyngeal and nasal swab spec...
  • Regulatory NewsRegulatory News

    FDA issues EUA for saliva-based COVID-19 test, provides path for wider home sample collection

    The US Food and Drug Administration (FDA) on Friday granted the first emergency use authorization (EUA) allowing for at-home saliva sample collection for a coronavirus disease (COVID-19) diagnostic and opened the door to wider at-home sample collection.   EUA   The EUA allows Rutgers Clinical Genomics Laboratory to use its TaqPath SARS-CoV-2 Assay, which was previously covered under the umbrella EUA for laboratory developed tests (LDT) for COVID-19, to test home co...
  • Regulatory NewsRegulatory News

    FDA abandons proposal for devices referencing drugs

    The US Food and Drug Administration (FDA) on Thursday said it will abandon a proposed regulatory approach for medical devices referencing drugs (DRDs) that would have allowed devices to be authorized for new uses with already approved drugs when the drugmaker does not want to collaborate on the new use.   The decision comes after FDA held a public hearing to discuss the scientific, regulatory and legal challenges posed by the approach in November 2017. At the time, FDA...
  • Regulatory NewsRegulatory News

    CDRH explains notification requirements for device shortages under CARES Act

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Wednesday issued immediately effective guidance explaining requirements for medical device makers to notify it of shortages during the coronavirus disease (COVID-19) pandemic.   Unlike drugmakers, device makers are not typically required to report shortages or discontinuances of their products to FDA; however, the Coronavirus Aid, Relief, and Economic Security Act (CARES ...
  • Feature ArticlesFeature Articles

    EU device regulations, COVID-19 response and global regulatory strategy

    Feature articles during April focused predominantly on the new European Medical Devices Regulation ( EU MDR ), In Vitro Diagnostic Medical Devices Regulation ( EU IVDR ) and the COVID-19 pandemic, with a number of regulatory experts examining the impact of pandemic-related delays on the progression of the European regulations. Also included were articles on the European Database on Medical Devices (Eudamed), the Mutual Recognition Agreement (MRA) between Switzerland an...
  • Regulatory NewsRegulatory News

    CE certificates up nearly 50% in 2019 in anticipation of MDR

    In its annual sector survey, the European notified body group Team-NB found a nearly 50% uptick in the number of new CE certificates issued in 2019 as medical device makers rushed to obtain the certificates before the application of the EU Medical Device Regulation (MDR).   While the MDR is now officially delayed by one year, companies planning for the transition in 2019 were braced for the regulation to take effect later this month. (RELATED: MDR delay official as i...