Jeff Shuren, Director of the Center for Devices and Radiological Health, highlights five pro-innovation changes underway within his group.

Jeff Shuren, Director of the Center for Devices and Radiological Health, talks about IDEs for early feasibility studies in the U.S.

Jeff Shuren, Director of the Center for Devices and Radiological Health, discusses the direct de novo pathway and the importance of pre-submission meetings.

Jeff Shuren, Director of the Center for Devices and Radiological Health, talks about what’s happening with the new International Medical Device Regulators Forum.

Jeff Shuren, Director of the Center for Devices and Radiological Health, offers his advice for medtech innovators seeking to bring new products to market in the U.S.

Jeff Shuren, Director of the Center for Devices and Radiological Health, explains the basic principles of the agency’s new mobile health guidance.

Bakul Patel, Associate Director for Digital Health at CDRH, explains the FDA’s objectives in creating its new mobile health guidance.

Bakul Patel, Associate Director for Digital Health at CDRH, clarifies what mobile health devices are regulated by FDA and which fall into enforcement discretion.

Bakul Patel, Associate Director for Digital Health at CDRH, shares his perspective on interpreting the FDA’s mobile health guidance.