Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report

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Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report (2010)
Board on Population Health and Public Health Practice (BPH)

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. "Appendix C: Premarket Notification: A Key Element of US Medical Device Regulation--Larry Kessler and Philip J. Phillips." Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report. Washington, DC: The National Academies Press, 2010.

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Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing patient Safety and Innovation - Workshop Report

REFERENCES

FDA (US Food and Drug Administration). 1986. Guidance on the CDRH Premarket Notification Review Program 6/30/86 (K86-3). http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm081383.htm (accessed July 21, 2010).

FDA. 1997. Deciding When to Submit a 510(k) for a Change to an Existing Device. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080235.htm (accessed July 21, 2010).

FDA. 2002. The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/uc m085994.htm (accessed July 21, 2010).