• Regulatory NewsRegulatory News

    Euro Convergence: Experts advise on ways to manage the MDR grace period

    Medical device companies in Europe have much work to do to get their products compliant with the EU’s new Medical Device Regulation (MDR) and should not be wasting any time, asserted a panel of experts who spoke at RAPS Euro Convergence 2021 on 10 May.   At the virtual meeting, the experts gave some concrete advice for device manufacturers to ready themselves for a seamless transition.   The EU Medical Device Regulations (MDR) is a new set of new regulatory require...
  • RF Quarterly

    Initiating clinical trials in China: What foreign medtech companies need to do

    This article discusses numerous recent changes in the regulation of clinical trials in China and proposes that Chinese clinical trials for medical device and in vitro diagnostic device (IVD) products are an increasingly viable option for non-Chinese companies of all sizes. [Updated]*   China’s regulatory framework Most life sciences products, including medical devices and IVDs, sold in China are supervised by the National Medical Products Administration (NMPA).  The ...
  • Regulatory NewsRegulatory News

    WHO's Essential Diagnostics List updated for COVID-19

    The World Health Organization (WHO) updated its list of essential diagnostics for 2021 on Friday to include recommendations for polymerase chain reaction and antigen-based diagnostic tests for COVID-19.   In making this and other recommendations to the “basket of recommended in vitro diagnostics” that makes up the organization’s Essential Diagnostic List (EDL), WHO also recommended additional tests that detect disease preventable by vaccines and other infectious dise...
  • Feature ArticlesFeature Articles

    COVID-19 IVD test kits: Expedited response by Asian regulatory authorities

    After COVID-19 quickly spread from China to nearby Asian countries in early 2020, regulatory authorities in those neighboring countries adapted rapidly to introduce regulatory pathways for approval of in vitro diagnostic (IVD) test kits to facilitate widespread testing and halt spread of the disease. An additional challenge was that authorities had to work around strict quarantine restrictions, and applications and consultations had to be conducted online instead of in per...
  • Regulatory NewsRegulatory News

    COVID antigen tests carry false positive risk: FDA

    Antigen tests for COVID-19 can yield false positive results, especially when used improperly, said the US Food and Drug Administration (FDA) in a notification sent to clinical laboratory staff and health care providers.   “Remember that positive predictive value (PPV) varies with disease prevalence when interpreting results from diagnostic tests,” said FDA in the 3 November letter . Lower disease prevalence in a given area or population increases the number of false p...
  • Feature ArticlesFeature Articles

    Initiating clinical trials in China: What foreign MedTech companies need to do

    This article discusses recent changes to clinical trial regulation in China. The author suggests that Chinese clinical trials for medical devices and in vitro diagnostic device (IVD) products are an increasingly viable option for non-Chinese companies of all sizes.   Introduction: China’s regulatory framework Most life sciences products sold in China, including medical devices and IVDs, are supervised by the National Medical Products Administration (NMPA), formerly k...
  • Regulatory NewsRegulatory News

    COVID-19 IVD quality problems drive EC guidelines

    A “mismatch” between the expected and actual quality of coronavirus (COVID-19) tests has spurred new guidelines from the European Commission (EC). The guidelines are part of a roadmap to lifting the lockdown measures implemented to curb the spread of the disease across the European Union, according to an EC statement dated 15 April.   Governments across the European Union (EU) are working to step up testing capacity, recognizing that testing will play a key role in e...
  • Regulatory NewsRegulatory News

    FDA cautions antibody test developers against falsely claiming tests are authorized

    After opening the door to commercial manufacturers and laboratory developers to market serological tests to detect antibodies to the novel coronavirus (SARS-CoV-2), with minimal regulatory oversight, the US Food and Drug Administration (FDA) is cautioning against companies falsely claiming their tests are approved or authorized.   Public health authorities and experts around the world view serological testing as a means of identifying people who have already had COVID-...
  • Regulatory NewsRegulatory News

    FDA issues first EUA for coronavirus serology test

    In a move that could help the US better understand who has already had COVID-19, the US Food and Drug Administration (FDA) on Thursday provided the first Emergency Use Authorization (EUA) for a serology test to North Carolina-based Cellex Inc. The test can detect SARS-CoV-2 antibodies, immunoglobulin M (IgM) and immunoglobulin G (IgG) that are generated as part of the human immune response to the virus. Although FDA recommends that results from serology testing should n...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Streamlined IVD Reviews for Cancer Clinical Trials

    As part of a push to reduce administrative burdens, the US Food and Drug Administration (FDA) on Wednesday finalized guidance on an optional streamlined submission process for determining the risk of an investigational in vitro diagnostic (IVD) in a clinical trial where an investigational IVD is being co-developed with an oncology investigational drug. The submission process, first proposed in draft guidance in April 2018 , is meant to help sponsors determine if an IVD...
  • Regulatory NewsRegulatory News

    IMDRF Takes Another Stab at IVDs, MDSAP

    Medical device regulators launched new initiatives on harmonizing in vitro diagnostic (IVD) regulations and tweaking the Medical Device Single Review Program (MDSAP) for additional countries to participate. A new working group (WG) was established to take up new work on IVDs and was approved at the last International Medical Device Regulators Forum (IMDRF) management committee meeting in Russia in March. A new category for interested countries to participate in MDSAP ...
  • Regulatory NewsRegulatory News

    MDIC Works to Standardize Oversight of NGS-based Assays

    To advance the regulatory science of diagnostic testing and assay development, the Medical Device Innovation Consortium (MDIC) posted a new landscape analysis report Wednesday to provide a snapshot of all known projects related to next-generation-sequencing (NGS) oncology reference samples.   The landscape analysis report serves as a catalog of information on 35 projects marked as either completed, ongoing or under development. Projects were divided into five categorie...