• Regulatory NewsRegulatory News

    Safer technologies program finalized by FDA

    A newly finalized guidance from the US Food and Drug Administration (FDA) smooths the path for manufacturers of devices and device-led combination products that stand to improve the safety of existing treatment and diagnostic options for certain diseases and conditions.   The Safer Technologies Program for Medical Devices (STeP) is intended for devices and combination products that target conditions that are less serious than those covered by FDA’s Breakthrough Devices...
  • Regulatory NewsRegulatory News

    In final guidance, FDA advises boxed warning for power morcellators

    A boxed warning and more explicit and detailed information about the risks associated with laparoscopic power morcellators should be included in labelling of the gynecologic surgery device, according to newly finalized guidance from the US Food and Drug Administration (FDA).   The guidance follows a February 2020 draft version issued in the wake of “numerous” published reports and Medical Device Reports (MDRs) describing “iatrogenic disseminarion, implantation, and s...
  • Regulatory NewsRegulatory News

    FDA extends timeline for device submissions on hold during pandemic

    The US Food and Drug Administration (FDA) on Tuesday revised its guidance on meetings and user fee applications for medical devices during the COVID-19 pandemic to give device sponsors more time to submit responses to the agency for applications or submissions that are on hold.   The guidance, initially released in June, was also updated to note that it can hold advisory committee meetings virtually, something the agency was still reviewing the feasibility of at the ti...
  • Regulatory NewsRegulatory News

    MDCG clarifies remote audit expectations for notified bodies

    The European Commission’s Medical Device Coordination Group (MDCG) released a new questions and answers document clarifying expectations for notified bodies looking to conduct remote audits of medical device manufacturers during the COVID-19 pandemic.   The document is meant to answer “operational and practical implementation” questions raised in response to the committee’s MDCG 2020-4 guidance released in the early months of the pandemic. (RELATED: Notified body aud...
  • Regulatory NewsRegulatory News

    Shuren previews 2021 priorities for CDRH

    With much of his center’s 2020 agenda on hold due to the COVID-19 pandemic, Jeffrey Shuren, director of the US Food and Drug Administration’s (FDA) Center for Devices and Radiologic Health (CDRH) on Thursday shared some of his hopes for next year on a call with the Alliance for a Stronger FDA.   “COVID-19 has essentially disrupted the trajectory of the medical device program in 2020. If you really think about it, 2021 is going to be a bit more of a reset,” Shuren said,...
  • Regulatory NewsRegulatory News

    FDA finalizes feedback processes for combo products

    Developers of combination products have new final guidance from the US Food and Drug Administration about requesting feedback from the agency during the full product development cycle.   In response to feedback received during the consultation period on the January 2020 draft guidance, FDA has adjusted the final guidance to give developers more information about the best use of combination product agreement meetings (CPAMs) as well as how agreements reached through CPA...
  • Regulatory NewsRegulatory News

    Device shortage guidance gets a COVID update from FDA

    An updated guidance from the US Food and Drug Administration (FDA) clarifies how the agency is handling device shortages and cessation in manufacturing during the public health emergency of the COVID-19 pandemic.   The FDA’s Center for Devices and Radiological Health updated the guidance, entitled “Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency,” so...
  • Regulatory NewsRegulatory News

    EC names fifth notified body for IVDR

    The European Commission (EC) has announced designation of a fifth notified body for the European Union In Vitro Diagnostic Regulation (IVDR). TÜV Rheinland, the new notified body, was also designated a notified body for the upcoming Medical Device Regulation (MDR) in 2019. (Related: TÜV Rheinland becomes 5th notified body designated under MDR , Regulatory Focus 26 September 2019)   Implementation of MDR has been delayed by a year to May 2021 because of concerns abou...
  • Regulatory NewsRegulatory News

    Eudamed launched with actor registration module live

    The European Commission’s Eudamed database, a critical component of the EU’s Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), launched on Tuesday with the actor registration module available to member states and economic operators.   “Eudamed will provide a living picture of the lifecycle of medical devices that are made available in the [EU],” the Commission writes, noting that the aim of the database is to increase transparency for medi...
  • Feature ArticlesFeature Articles

    November's Regulatory Focus: US, China, and EU: Regulatory and strategic considerations

    Feature articles during November focused on a range of topics, including a comparison of US drug regulatory pathways with those in China, as well as the application of EU and US guidelines during product development for advanced therapies. The line-up also included articles on the challenges in getting contemporaneous approval for medicines and companion diagnostics, and the importance of early planning in preparation for the transition to the EU In Vitro Diagnostic Devi...
  • Feature ArticlesFeature Articles

    Comparison of pharmaceutical development drug regulatory pathways in the US and China

    The US has the largest pharmaceutical market in the world, as well as the highest expenditure in research and development (R&D). Right behind the US is China, in second place, as it steadily closes the gap, with increasing government investment in R&D and programs promoting the development of innovative medicines targeting the global market. To close that gap, there should be a strong R&D infrastructure, effective intellectual property protection, integration in global sta...
  • Regulatory NewsRegulatory News

    Statutory deadline for OTC hearing aid rule missed by FDA

    Despite ongoing assurances that it will address the matter of over-the-counter hearing aids, the US Food and Drug Administration (FDA) has missed another deadline to issue a proposed rule on the devices.   According to correspondence sent by two US senators to FDA Commissioner Stephen Hahn, MD on 13 October, FDA has missed its statutory deadline of 18 August 2020 to issue proposed guardrails for the marketing of over-the-counter (OTC) hearing aids, as required in the 2...