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[Standards used in the regulation of medical device in USA]
1Tianjin University of Medical Sciences, Tianjin, 300070, PR China.
Objective:
To study the USA government's administrative system about medical device standards as well as the standard making.
Methods:
The relevant documents, regulations, website that USA Food and Drug Administration announced were extensively reviewed, knowing the USA medical device standards synthetically.
Results:
The USA standards system of medical device included regulatory requirements and voluntary consensus standards. This article simply introduced the laws, regulations, performance standards and consensus standards.
Conclusion:
The USA's administrative system about medical device standards as well as many standards can be referenced.
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