1. 42 U.S.C. § 1395 y(a) (1)(A) (2000)
2. see also Centers for Medicare & Medicaid Services, U.S. Department of Health and Human Servs., Pub. No. 100-2, Medicare Benefit Policy Manual, ch. 16, § 20, Available at: http://www.cms.hhs.gov/manuals/downloads/bp102c16.pdf. Accessed August 7, 2008.
3. Available at: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_bills&docid=f:h6331enr.txt.pdf. Accessed November 24, 2008.
4. 21 C.F.R. § 814.2. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=814.2. Accessed September 24, 2008.
5. 21 C.F.R. Part 807. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=807. Accessed September 29, 2008.