8FDA. Guidance on IDE Policies and Procedures[S]. IDE Staff, Office of Device Evaluation, Center for Devices and Radiological Health, US FDA, 1998-01-20.
9US Department of Health and Human Services. Code of Federal Regulations[ EB/OL]. [ 2006-11 ]. http ://www. accessdata. fda. gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch, cfm.
10US Department of Health and Human Services. The definition of Medical Device[ EB/OL]. [2007-03 ]. http ://www. fda. gov/cdrh/devadvice/312, html.