1. U.S. Code 21 (h) Food, Drug, and Cosmetic Act. Web addresshttp://www.fda.gov/opacom/laws/fdcact/fdcact1.htm(Accessed August, 2009).
2. Clinical trials of the effectiveness of devices: An analogy with drugs
3. Statistics in the World of Medical Devices: The Contrast with Pharmaceuticals
4. U.S. Code of Federal Regulations, Title 21 (Food and Drugs), U.S. Government Printing Office, Washington, DC, 2001, Part 860.7 Web addresshttp://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr860_01.html(Accessed August, 2009).