title: [USA approval of high-risk medical device].
abstract: During the practice of supervision and management of medical device in different countries, the strict regulatory and needs of the program by the regulations is to be determined by the risk level of the medical equipment. This paper briefly describes the regulatory requirements of the United States to enter the market for high-risk medical device.
authors.affiliation: China center for pharmaceutical International excharge, Beijing, 100082. cyh0010532@sina.com
authors.forename: Yongheng
authors.initials: Y
authors.lastname: Chang
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety; D014481:United States