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Standards - Improving the quality of international medical device standards for regulatory use
Working Group Chair(s)
Food and Drug Administration (FDA)
United States of America
Scott.Colburn [at] fda.hhs.gov
Regulator and stakeholder (membership to be advised)
The purpose of this Work Item is to identify and explore possibilities to improve the process of developing international standards used for regulatory purpose in the medical technology domain. Further information on this Work Item is included in the attached presentation.
The scope of this Work Item will include the mapping of technical issues and concerns, with regard to regulatory aspects of standards developed by some major international standardization committees. It will also explore possibilities for improvement and discuss these with stakeholders and SDOs, and describe possible actions IMDRF could take to influence and support the development or amendment of standards for regulatory purposes.