• Feature ArticlesFeature Articles

    An overview of recent FDA activity on materials in medical devices

    In this article, the authors provide an overview of recent US Food and Drug Administration (FDA) interest and activity relating to the materials in implants regulated as medical devices. Since 2019, the increase in public and regulatory scrutiny of medical implants has resulted in an FDA advisory committee meeting, revised corrosion testing guidance, and proposed new labeling disclosures.   Introduction Medical devices offer innovative ways of treating various cond...
  • Regulatory NewsRegulatory News

    CDRH Draft Guidance Tackles Nitinol Devices

    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. The draft guidance FDA’s Center for Devices and Radiological Health (CDRH) issued on Thursday covers the types of information to include in premarket submissions of devices made from nitinol, including material composition and manufacturing parameters, pseudoelasticit...