• Regulatory NewsRegulatory News

    CDRH Draft Guidance Tackles Nitinol Devices

    • 18 April 2019
    As part of a broader effort to address potential safety issues from materials in medical devices, the US Food and Drug Administration (FDA) proposed technical considerations for nitinol-containing devices.
     
  • Regulatory NewsRegulatory News

    Australia and Canada Jointly Approve Breast Cancer Drug

    • 18 April 2019
    As part of a push toward regulatory convergence, Health Canada and Australia’s Therapeutic Goods Administration (TGA) last week jointly approved Eli Lilly’s Verzenio (abemaciclib) for the treatment of metastatic breast cancer.
     
  • Regulatory NewsRegulatory News

    CDRH Drafts Guidance on Quantitative Imaging

    • 18 April 2019
    Manufacturers looking for premarket submission recommendations for medical devices that generate quantitative imaging values have a new resource as the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released draft guidance Thursday.
     

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  • FDA Proposes Major Changes to Mammography Regulations

    • 27 March 2019
    The US Food and Drug Administration (FDA) on Wednesday proposed a new rule that would modernize mammography regulations and require mammography facilities to provide patients with more information on breast density.
     
  • FDA Drafts Guidance on Inspections of Medical Device Establishments

    • 28 March 2019
    The US Food and Drug Administration (FDA) issued draft guidance on Thursday to implement uniform processes and standards for FDA inspections of domestic and foreign medical device establishments.
     
  • FDA to Launch New Website Next Week

    • 16 April 2019
    In his first “all hands” speech at the US Food and Drug Administration’s (FDA) White Oak campus on Tuesday, Acting Commissioner Ned Sharpless explained how he will pick up where Scott Gottlieb left off, and how next week, FDA will launch a new and improved FDA.gov website.
  • EU Device Coordination Group Offers Eudamed Guidance

    • 15 April 2019
    The EU’s Medical Device Coordination Group (MDCG) on Monday released two new documents explaining how legacy devices can be registered in Eudamed without a unique device identifier (UDI) and how device companies will have until November 2021 to register device data elements in Eudamed.
     
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