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  • Regulatory NewsRegulatory News

    FDA expands guidance on remote monitoring devices for COVID-19

    Guidance on use of non-invasive remote monitoring devices for patient care during the coronavirus public health emergency was expanded and updated by the US Food and Drug Administration (FDA) on Friday.  The guidance , originally issued in March, addresses the emergency of the coronavirus (COVID-19) pandemic by allowing modifications that “may increase access to important patient physiological data without the need for in-clinic visits,” as well as facilitating both in...
  • Regulatory NewsRegulatory News

    European Commission updates on MDR, IVDR implementation timeline

    The European Commission this week updated its “rolling plan” for adopting implementing acts and other measures ahead of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).   The update follows the move to delay the implementation of MDR by one year due to the coronavirus disease (COVID-19) pandemic and the decision to delay Eudamed’s rollout by two years last December. (RELATED: MDR delay official as industry calls to push back IVDR , ...
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    FDA releases EUA template for COVID-19 home sample collection kits

    The US Food and Drug Administration (FDA) on Friday released a new emergency use authorization (EUA) template to assist test makers in developing at-home sample collection kits for use with tests for coronavirus disease (COVID-19).   The new template comes after FDA authorized several tests and a standalone sample collection kit for at-home sample collection from testing companies including LabCorp, Quest Diagnostics, Everlywell and PrivaPath Diagnostics. (RELATED: F...
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    Health Canada releases guidance to streamline COVID-19 clinical trials

    Health Canada Wednesday issued two guidance documents designed to streamline clinical trials for medical devices and drugs that are related to COVID-19.   The guidance documents support an interim order (IO) that reduces the administrative burden of clinical trials and promotes efficient investigation of drugs and medical devices to treat, prevent, mitigate or diagnose COVID-19.   The IO has dropped administrative requirements for non-significant changes during a...
  • Feature ArticlesFeature Articles

    Making the call to test in-house or outsource

    With dynamics across the medical device industry continuing to evolve, manufacturers should evaluate their current standing to ask themselves if they should perform in-house testing, outsource or a combination of both. This article discusses key considerations before making a final decision.   Introduction   Transitioning to the stringent requirements of the European Union Medical Devices Regulation ( EU MDR ) continues to pose significant hurdles for medical dev...
  • Regulatory NewsRegulatory News

    FDA issues guidance on PMA, HDE supplements amid COVID-19

    The US Food and Drug Administration (FDA) on Thursday issued an immediately effective guidance allowing medical device makers to make “limited modifications” to their devices without submitting a premarket approval (PMA) or humanitarian device exemption (HDE) supplement or a 30-day notice during the coronavirus disease (COVID-19) public health emergency.   FDA says the policy is meant to give device makers additional flexibility to address supply chain issues stemming ...
  • Regulatory NewsRegulatory News

    MHRA launches dedicated COVID-19 Yellow Card site

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday launched a dedicated site for reporting side effects and incidents related to medicines and medical devices used in patients infected with SARS-CoV-2, the novel coronavirus that causes COVID-19.   The COVID-19 Yellow Card reporting site is meant to “enable the MHRA to rapidly identify new and emerging side effects and medical device incidents in COVID-19 treatment, including side effects ...
  • Regulatory NewsRegulatory News

    FDA names companies removed from antibody test list

    After tightening its oversight of antibody tests for coronavirus disease (COVID-19) earlier this month, the US Food and Drug Administration (FDA) on Thursday began publicly listing commercial manufacturers that have either failed to submit an emergency use authorization (EUA) request or voluntarily withdrew notification for their antibody tests distributed under the agency’s former policy.   In its initial policy in March, FDA said it would not object to the developmen...
  • Regulatory NewsRegulatory News

    EC eases rules for renewing notified body designations, explains process for EU-wide derogations

    The European Commission has issued new regulations easing the process for renewing notified body designations prior to the new date of application for the Medical Devices Regulations (MDR), 26 May 2021.   The move comes as the Commission works to realign the various components of its regulatory framework for medical devices to accommodate the one-year MDR delay necessitated by the coronavirus disease (COVID-19) pandemic and the two-year Eudamed delay announced last y...
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    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...