North America - Aug 2019

  • Canada: New fees and performance standards for medical devices effective 1 April 2020

  • Canada: New medical device incident reporting requirements for hospitals

  • Canada: Post-market surveillance requirements proposed for adoption

  • Canada: Guidance on pre-market requirements for medical device cybersecurity

  • Canada: Guidance on ‘Management of Applications for Medical Device Licences’ has been updated

  • Canada: Supporting evidence for 3D printed implantable devices set out in new guidance document

  • USA: Updated procedures to request supervisory review of certain CDRH decisions concerning medical devices

  • USA: Final guidance on using animal studies to evaluate organ preservation devices

  • USA: Guidance outlines ways for requesting feedback and meetings for device submissions

  • USA: Guidance issued on live case presentations during IDE clinical studies

  • USA: Guidance makes recommendations on content and format of non-clinical bench performance testing information in pre-market submissions

  • USA: Characterisation of UHMWPE material used in orthopaedic devices

  • USA: UDI labelling requirements: definitions for convenience kits and medical procedure kits are clarified

  • USA: Policy clarification for certain fluoroscopic equipment requirements

  • USA: Guidance on conformance of medical x-ray imaging devices with IEC standards

  • USA: Guidance on obtaining marketing clearance for diagnostic ultrasound systems and transducers

  • USA: Guidance for applicants on submitting safety information for combination medical products

  • USA: FDA issues two final guidance documents on laser products

  • USA: Clinical investigations for prostate tissue ablation devices – guidance drafted

  • USA: Mouse embryo assays for assisted reproduction technology devices

  • USA: Recommendations drafted on testing for biotin interference in IVDs

  • USA: Illinois takes tough stance on ethylene oxide emissions

  • USA: FDA updates recognised consensus standards database

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