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  • 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...
  • Regulatory NewsRegulatory News

    MedTech Europe Urges Tailored Approach to Validating Biomarker Assays

    MedTech Europe issued a discussion paper to propose a fit-for-purpose approach for the validation of biomarker assays used in early clinical trials, offering three new guiding principles. The 8-page discussion paper takes issue with a trend among some competent authorities seeking to mandate CE marking on predictive biomarker assays prior to being used in clinical trials. It asserts that industry agrees with “overarching safety goals” that assays should be appropriately...
  • Regulatory NewsRegulatory News

    CDRH Seeks to Exempt Certain Flow Cytometers from 510(k) Reviews

    The US Food and Drug Administration (FDA) issued a proposed order Tuesday to exempt certain flow cytometer instruments from 510(k) requirements. The flow cytometer instruments are currently regulated by the agency as class II devices, which are subject to 510(k) reviews. But FDA’s Center for Devices and Radiological Health (CDRH) has determined premarket notification is no longer necessary to provide reasonable assurance of safety and effectiveness prior to market entry...
  • Regulatory NewsRegulatory News

    FDA, CMS, CDC Launch Task Force for Emergency Diagnostics

    Three US Department of Health and Human Services agencies announced Tuesday the launch of the Tri-Agency Task Force for Emergency Diagnostics (TTFED) to better respond to public health emergencies. With the distinct roles set for each of the agencies, TTFED is intended to leverage the expertise of the US Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) around the development...
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    Proposed Precertification Approach on In Vitro Clinical Tests Raises Questions

    Comments submitted to Congress on a recent discussion draft for a new risk-based approach to the regulation of in vitro clinical tests (IVCTs) raised questions and concerns around the IVCT precertification framework. The IVCT draft legislation would provide regulatory standardization for FDA-reviewed tests and laboratory developed tests (LDTs)—most of which do not meet the same standards in analytical and clinical validation—whereas IVCT precertification would enable ...
  • Regulatory NewsRegulatory News

    FDA Draft Guidance on Broader Labeling for Oncology Companion Diagnostics Draws Mixed Reactions

    Developers of companion diagnostic (CDx) tests as well as pharmaceutical and biotechnology groups and companies expressed mixed reactions to the US Food and Drug Administration (FDA) draft guidance on broader labeling of in vitro CDx assays for a specific group or class of oncology therapeutic products. The support and concerns were expressed through comments recently submitted to FDA’s draft guidance document, which was released  last December. Some commenters showe...