• Regulatory NewsRegulatory News

    MDR/IVDR: Commission updates on implementation, notified body designation

    The European Commission last week updated its rolling plan detailing the actions and initiatives necessary to ensure the smooth rollout of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).   With MDR’s date of application just weeks away, Finland’s Eurofins Expert Services Oy on Wednesday became the 20 th notified body designated under the regulation. Just four notified bodies have been designated under IVDR.   Based on the pipeli...
  • Feature ArticlesFeature Articles

    Communication of regulatory intelligence: A survey of the medical device industry

    Regulatory intelligence activities are complicated by the push for stronger product sales in emerging markets, where medical device regulations can change rapidly or be confusing and even contradictory. Understanding how, when, and with whom to communicate the new or changing regulatory information within a medical device company affects global market strategy and product success. The research reported here examined how medical device companies structure their regulatory i...
  • ReconRecon

    Recon: EMA says 'possible' AZ-blood clot link; Invitae's $1.2B gene testing investment

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. begins study on allergic reaction risk in Moderna, Pfizer vaccines ( NIH ) ( Reuters ) CDC says variant from the UK is now the most common strain circulating in the U.S. ( CNBC ) U.S. delivering about 3 million COVID-19 vaccines per day, up 8%: CDC director ( Reuters ) U.S. surpasses 150 million vaccine shots under Biden, on track to hit President’s new 2...
  • Regulatory NewsRegulatory News

    How to reduce bias, improve fairness in medical devices

    Lessons learned in the artificial intelligence community about addressing bias could also be applied to medical devices, according to a recent perspective in the journal Science .   “Initiatives to promote fairness are rapidly growing in a range of technical disciplines, but this growth is not rapid enough for medical engineering. Although computer science companies terminate lucrative but biased facial recognition systems, biased medical devices continue to be sold a...
  • Regulatory NewsRegulatory News

    HHS proposes updates to patient labeling, BA/BE study regulation

    The US Department of Health and Human Services (HHS) has released its semiannual inventory of proposed rulemaking actions, with a relatively brief to-do list for drug and medical device regulators.   For the US Food and Drug Administration (FDA), actions sitting at the proposed rule stage include an amendment to 21 CFR 320 to clarify FDA’s expectations for the conduct of analytical and clinical pharmacology as well as bioavailability and bioequivalence studies to suppo...
  • 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...