A Candid Look At The 510(k) process for FDA Approval

At this year’s OneMedForum SF, InHealth, the Institute for Health and Technology Studies, partnered with OneMedPlace to produce a panel discussion on improving the 510(k) process for FDA approval.

On this panel was William H. Maisel, MD, Deputy Director for Science, FDA Center for Devices and Radiological Health; Jan B. Pietzsch, PhD, President and CEO of Wing Tech Inc. and Consulting Associate Professor of Management Science and Engineering at Stanford University; Josh Makower, MD, MBA. President and CEO at ExploraMed; and Ralph F. Hall, Distinguished Professor at the University of Minnesota Law School. Steven Halasey, Vice President for Programs at InHealth, moderated the panel.

The event was unique in that it brought together entrepreneurs, researchers, and regulators to present their respective viewpoints in one setting. After the event, feedback from participants and attendees alike was very positive.

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