References
- US Federal Food and Drugs Act. Public Law 59–384, 34 stat. 768 (1906).
- Merrill RA. The architecture of government regulation of medical products. Va. L. Rev.82(1753), 1802 (1996).
- Henderson JA, Alexander BC, Lewis AP, Smith JJ. The MDUFMA User Fee Program in 2005: A critical year. Center for Integration of Medicine and Innovative Technology, 1–9 (2005).
- Post Safe Medical Device Act (SMDA). Public Law 91–4243 (1990).
- Post Safe Medical Device Act (SMDA). Public Law 102–300, 106 Stat. 238 (1992).
- US Code of Federal Regulations (CFR) Title 21. 814 (h).
- Kaplan AV, Harvey ED, Kuntz RE, Shiram H, Robb JF, Fitzgerald P. Humanitarian use devices/humanitarian device exemptions in cardiovascular medicine. Circulation112, 2883–2886 (2005).
- US Code of Federal Regulations (CFR) Title 21. 814.3 (n).
- US Code of Federal Regulations (CFR) Title 21. 814.104(b)(2).
- US Code of Federal Regulations (CFR) Title 21. 814.104(b)(5).
- The Pediatric Medical Device Safety and Improvement Act. Public Law 110–185 (2007).
- US Code of Federal Regulations (CFR) Title 21. 814.124(a)
- Radinsky G. Preventing coverage delays is key to device profits. Med. Device Technol.1–6 (2004).
- The Lewin Group. Outlook for Medical Technology: Will Patients Get the Care They Need? Report 2, the Medicare Payment Process and Patient Sccess to Technology. AdvaMed, DC, USA (2000).
Websites
- Advamed website. Harvey ED. AdvaMed 15th annual device submissions workshop (2005). www.fda.gov/cdrh/present/advamed-052505-harvey-hde.ppt
- US Food and Drug Administration www.fda.gov/CDRH/
- FDA website. Humanitarian Device Exemption (HDE) Regulation: questions and answers (2006). www.fda.gov/cdrh/ode/guidance/1381
- American Academy of Pediatrics Website. Summary of innovations in the Medical Device Safety and Improvement Act of 2007.www.aap.org/advocacy/washing/Therapeutics/index
- FDA Website. Draft Guidance for HDE Holders, Instituional Review Boards (IRBs), Clinical Investigators, and FDA Staff. www.fda.gov/cdrh/ode/guidance/1668
- FDA Website. Humanitarian Use Devices. Listing of CDRH humanitarian device exemption summaries of safety and possible benefit. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfHDE/HDEInformation.cfm