[Standards used in the regulation of medical device in USA].
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.


CONCLUSIONS
The USA's administrative system about medical device standards as well as many standards can be referenced.
Hu
Wei
W
Tianjin University of Medical Sciences, Tianjin, 300070, PR China.
Gu
Hanqing
H
D018795:Device Approval / Q000331:legislation & jurisprudence / Q000592:standards; D004869:Equipment Safety / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D006801:Humans; D011786:Quality Control; D023822:Tissue Engineering / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration