Practical Advice for Medical Devices Firms

www.clinipace.com References American College of Radiology. National Medicare Coverage Decisions. Available at: http://www.acr.org/Hidden/Economics/FeaturedCategories/Coverage/n mcd.aspx. Accessed April 29, 2011. Neumann P, Kamae MS, Palmer JA. Medicare’s National Coverage Decisions for Technologies, 1999-2007. Health Affairs 2008;27(6):162031. U.S. Department of Health & Human Services. Centers for Medicare & Medicaid Services. Healthcare Common Procedure Coding System (HCPCS) Level II Coding Procedures. Updated June 2010. Available at: https://www.cms.gov/MedHCPCSGenInfo/02_HCPCSCODINGPROCESS.as p#TopOfPage. Accessed April 29, 2011. U.S. Food and Drug Administration. IDE Approval Process. Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/How toMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm046164.ht m#who_apply. Accessed April 29, 2011. U.S. Food and Drug Administration. Overview of Device Regulation. Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Ove rview/default.htm. Accessed April 29, 2011. Page | 12 ©2012 Clinipace Worldwide, Inc. All rights reserved.

Practical Advice for Medical Devices Firms | Page 12