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.
Citation： HU Wei,GU Hanqing.. STANDARDS USED IN THE REGULATION OF MEDICAL DEVICE IN USA. Chinese Journal of Reparative and Reconstructive Surgery, 2007, 21(11): 1263-1267. doi: Copy