• Regulatory NewsRegulatory News

    FDA okays first-in-world valve to address congenital heart disease

    The US Food and Drug Administration (FDA) announced Friday that it approved a first-in-world device to address pulmonary valve regurgitation in patients with some kinds of congenital heart disease, along with a device meant to help gait problems in people with multiple sclerosis.   The Harmony Transcatheter Pulmonary Valve (TPV) system is a less invasive option than open-heart repair for severe pulmonary valve regurgitation in patients with a native or surgically repai...
  • Regulatory NewsRegulatory News

    Shuren and Stenzel: Bending the arc of testing for COVID – and beyond

    The U.S. Food and Drug Administration’s efforts to rapidly authorize point-of-care and at-home tests during the COVID-19 pandemic could offer a roadmap for a broad effort to bring diagnostic and screening tests to homes and remote locations for a variety of diseases. “The development and authorization of COVID-19 [point-of-care] and at-home tests has been remarkable; a process that can often take more than a year took only a few months in many cases. We believe that les...
  • Regulatory NewsRegulatory News

    Device, digital health firms oppose HHS’ proposed 510(k) exemptions

    Medical device and digital health companies have largely come out in opposition to a proposal from the Department of Health and Human Services (HHS) to permanently exempt 84 types of medical devices from premarket notification (510(k) requirements.   The proposal was made in the final days of the Trump administration and was pushed through without consulting the US Food and Drug Administration (FDA), the agency that would typically issue such a notice. All the devices ...
  • ReconRecon

    Recon: uBiome founders garner $60m SEC fraud charge; Idera's melanoma drug flops Ph 3

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US FDA Explores Pandemic Inspection Alternatives, Post-Pandemic Strategies ( Pink Sheet ) Experts Warn U.S. Could See New Coronavirus Hot Spots ( NPR ) Biden says 65% of people 65 or older have received at least one COVID vaccine shot ( Reuters ) Drugmakers brace for a pricing fight as Xavier Becerra is confirmed as the next HHS secretary ( Endpoints ) New HH...
  • Regulatory NewsRegulatory News

    FDA offers real-world evidence examples in device applications

     The US Food and Drug Administration (FDA) is offering a detailed look at how real-world evidence sources – from registries to claims data – can be used to support marketing applications for medical devices.   A new report from the FDA’s Center for Devices and Radiological Health (CDRH) breaks down 90 examples in which real-world evidence was used to support final premarket or postmarket regulatory decisions from Fiscal Year 2012 through 2019. These examples include ...
  • Regulatory NewsRegulatory News

    Updated: FDA smooths the path for COVID screening tests

    Editor’s note: This story has been updated to include remarks and perspective from an FDA Town Hall for test developers.   At the one-year mark of the public health emergency of the pandemic, the US Food and Drug Administration (FDA) is providing a smoother road to the authorization of COVID-19 tests to screen asymptomatic individuals.   On Tuesday, FDA issued a fact sheet for those who are interested in setting up screening programs, an update to its FAQ do...
  • MDCG releases rapid COVID antibody test guidance

    Europe’s Medical Device Coordination Group (MDCG) has set out guidance for developers of rapid COVID-19 antibody tests, identifying minimum performance criteria and considerations for devices intended to detect antibodies against SARS-CoV-2.   In formulating the guidance , MDCG looked to other regulators’ considerations for antibody tests, including the World Health Organization (WHO). Additionally, the working group reviewed the instructions for use from 102 separate...
  • Regulatory NewsRegulatory News

    MDCG addresses custom devices under MDR

    The European Commission’s Medical Device Coordination Group (MDCG) on Monday issued a new questions and answers document addressing custom-made medical devices under the Medical Device Regulation (MDR) and providing considerations for adaptable and patient-matched devices.   Custom-made devices (CMDs) are defined under MDR as devices made specifically in accordance with a written prescription by an authorized person that have specific design characteristics and are i...
  • 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 ...
  • ReconRecon

    Recon: 2021's priciest drugs; A leaderless FDA?

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novartis' canakinumab failed to improve survival in Phase III trial ( Reuters ) ( Endpoints ) Is a leaderless FDA clamping down on drug reviews? Not knowing is weighing heavy on biotech ( STAT ) Pandemic Forces FDA to Sharply Curtail Drug Company Inspections ( NYT ) A Survey of Survival Outcomes for Targeted Cancer Drugs Approved by the US Food and Drug Admini...
  • Regulatory NewsRegulatory News

    Global medicinal supply chain examined in EC, US efforts

    The European Commission has launched a structured dialog addressing pharmaceutical supply chain initiatives, aiming to safeguard the security of the European Union’s supply of medicines. A 26 February launch meeting kicked off the structured dialog initiative, which brings together national authorities, patients, nongovernmental organizations working in the health sector and members of the research community.   By coming to a clearer understanding of how global medical...
  • Regulatory NewsRegulatory News

    FDA: Oximeters may be inaccurate in Black patients

    The US Food and Drug Administration (FDA) has issued a new safety communication about the limitations of using pulse oximeters to assess blood oxygen levels. The communication is based in part on findings that oximeters may yield falsely elevated readings in individuals with dark skin pigmentation, with the potential of masking dangerously low blood oxygen levels.   The agency’s communication comes in the context of the COVID-19 pandemic, which “has caused an increase ...