North America - Nov 2020

  • USA: FDA medical device user fees for fiscal year 2021 increase by about 7%

  • USA: Proposed changes to regulations covering ‘intended use’

  • USA: Non-invasive bone growth stimulators proposed for down-classification

  • USA: Reclassification of CMV DNA quantitative assay devices proposed

  • USA: Two guidances published to support Safety and Performance Based Pathway

  • USA: FDA issues final guidance on breast implant labelling recommendations

  • USA: Guidance published on policy and considerations for multiple function device products

  • USA: Updated guidance on the use of ISO 10993-1 for biological evaluation of medical devices

  • USA: Two updated guidance documents issued for blood glucose monitoring test systems

  • USA: Updated guidance on conducting clinical trials of medical devices during the COVID-19 pandemic

  • USA: New guidance on recognition and withdrawal of voluntary consensus standards

  • USA: Technical considerations for non-clinical assessment of nitinol-containing medical devices

  • USA: Guidance issued on Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program

  • USA: Draft principles for selecting, developing, modifying, and adapting PRO instruments

  • USA: Advice provided on adverse event reporting for devices under EUAs or subject to COVID-19 related guidance

  • USA: CDRH publishes proposed guidance development lists for fiscal year 2021

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