• Regulatory NewsRegulatory News

    FDA expands eSTAR filing to de novo devices, IVDs

    US medical device and in vitro diagnostic sponsors who are using the Food and Drug Administration’s de novo pathway will be able to use the eSTAR filing format at the beginning of 2022. A pilot program for the eSTAR template that kicked off in 2020 began with a template for 510(k) device submissions.   Nine companies participated in that pilot program that trialed the interactive, PDF-based filing format. Use of eSTAR was expanded in September 2020 to include all 5...
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    FDA recognizes Memorial Sloan Kettering tumor variant database

    The first somatic human variant database has been recognized by the US Food and Drug Administration for inclusion in its Public Human Genetic Variant Database listing. The move opens the door for developers of tumor profiling tests to use the database to support clinical validity claims in regulatory submissions.   A portion of Memorial Sloan Kettering Cancer Center’s Oncology Knowledge Base (OnkoKB) received the recognition under FDA’s database recognition program. ...
  • Feature ArticlesFeature Articles

    Strategies for managing regulatory risk with third-party distributors

    In today’s global healthcare distribution market, an increasing number of medical device and in vitro diagnostic medical device (IVD) companies are aspiring to market globally. One of the main challenges these manufacturers face is how to register and distribute their products internationally. While direct distribution channels may be feasible for larger multinational corporations, third-party distribution brings its own advantages, and is becoming the norm in today’s land...
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    August’s Regulatory Focus: Alternative regulatory pathways

    Feature articles during August focused on alternative global regulatory pathways and their use in providing faster, easier access to new treatments for unmet medical needs. Articles examined emergency use authorizations for in vitro diagnostics (IVDs) in the US, as well as regulatory pathways for laboratory developed tests (LDTs), innovative medicinal products in Switzerland, software as a medical device (SaMD) in the US and Europe, and cell and gene therapy products in Ja...
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    Emergency use authorizations for IVDs: Building on lessons learned

    Emergency use authorization (EUA) is a tool used by the US Food and Drug Administration (FDA) for providing quick access to unapproved medical products in response to a public health emergency. In vitro diagnostics (IVDs) have been critical EUA products in past emergencies and have proven equally important during the COVID-19 pandemic. For regulatory professionals, the valuable lessons learned from EUA policy and ensuing changes over time have provided a crucial foundation...
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    The changing regulatory landscape for laboratory developed tests

    The COVID-19 pandemic has highlighted the importance of reliable and accurate diagnostic tests. Laboratory developed tests (LDTs) do not typically require premarket review. The US Food and Drug Administration (FDA) has repeatedly proposed more rigorous regulatory frameworks for LDTs but has been unsuccessful owing to concerns about the impact on test availability and innovation. In this article, the authors describe the existing regulations and consider both sides of the d...
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    EU IVDR compliance in a small organization

    This article presents a brief overview of the EU In Vitro Diagnostic Regulation (IVDR) requirements. It provides a user-friendly, step-by-step guide on how to comply with the regulation from first-hand experience and includes suggestions and tips for IVDR compliance through the lens of a small organization.   Understanding the changes of EU IVDR The IVDR, or Regulation 2017/746, 1 on in vitro diagnostics (IVDs) came into effect with its publication on 26 May 2017 ...
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    COVID-19 diagnostics: Moving from laboratory to home-based testing

    The US Food and Drug Administration (FDA) has worked closely with diagnostics developers during the past year to facilitate access to COVID-19 testing and accelerate development of home-based tests. By creating a flexible regulatory framework, the agency has enabled authorization of nearly one COVID-19 diagnostic per day, including at-home tests that have a critical role in the ongoing response to SARS-CoV-2. Introduction The emergence of the COVID-19 pandemic create...
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    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 ...
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    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...
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    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...