RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

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

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.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe

Regulatory Focus™ is doing essential, non-biased journalism during this unprecedented time. We appreciate your support as we bring you the news and intelligence you need to make an impact on global healthcare.

Regulatory Focus™ provides the intelligence you need to impact global healthcare during this crisis. Thank you for your support.