[1] Overview of the Office of Combination Products. Http: //www.fda.gov/oc/combination/overview.html. [2] Definition of a Combination Product http//www.fda.gov/oc/combination/definition.html（21 CFR § 3.2(e)，U.S）. [3] FDA Proposes Rule on “Combination” Products.http://www. Fda.gov/bbs/topics/ANSWERS/2004/ANS01288.html. [4] FDA：Primary Mode of Action Assignment Flowchart[2006-07-23] . Http://www. Fda. Gov/oc/combination/pmoa.pdf. [5] FDA：Guidance for Industry and FDA Staff: Application user Fees for Combination Products. [6] FDA：Combination Products Timeliness of Premarket Review; Dispute Resolution. [7] FDA：Current Good Manufacturing Practices Practices for Combination Products. [8] FDA：http://www.fda.gov/oc/combination/howtowrite.html.