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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