Regulatory Focus Interview With John Linehan and Jan Pietzsch—Study on the 510(k) Process

Posted 01 November 2010 | By

John H. Linehan, PhD, is a consulting professor of bioengineering in Stanford University's biodesign program and a clinical professor of biomedical engineering at Northwestern University, and Jan B. Pietzsch, PhD, is president and CEO of Wing Tech Inc. and a consulting associate professor in Stanford University's department of management science and engineering. Together, they are conducting a large-scale study of the US Food and Drug Administration (FDA) 510(k) process for medical devices. They have been meeting with regulatory professionals from industry and government to gather input for the study's design and recently visited RAPS headquarters in Rockville, MD.

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