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European system offers means to speed up FDA review

This article was originally published in Clinica

Executive Summary

US industry association HIMA urges consideration of the use of private sector, third-party organisations in the US to review certain medical devices. In a written statement to the Senate committee hearing on FDA reform, HIMA believes that this approach - a key element in its industry model legislation (see Clinica No 677, p 7) - "would be the single most effective means of ensuring that medical devices are reviewed within the timeframes Congress established by law".

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