_______. 2011. Public health effectiveness of the FDA 510(k) clearance process: Measuring postmarket performance and other select topics. Washington. DC: The National Academies Press.

Kahan, J. S. 2009. Medical device development: Regulation and law, Needham, MA: Parexel International.

OTA (Office of Technology Assessment). 1984. Federal policies and the medical devices industry. Washington, DC: Congress of the United States, Office of Technology Assessment.

Shuren, J. 2011. CDRH summary of public comments; issues for committee to consider. Silver Spring, MD, 01/21/2011.

Tillman, D. B. 2010. Understanding the premarket notification (510(k)) process. Presentation given at Public Health Effectiveness of the FDA 510(k) Clearance Process Committee, Meeting 1, March 1, 2010, Washington, DC.

von Eschenbach, A. C. 2007. Third party review of medical device premarket notifications. Report to the Committee on Energy and Commerce, U.S. House of Representatives, and the Committee on Health, Education, Labor, and Pensions, U.S. Senate. Washington, DC.

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