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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