Video Library

Currently Viewing: Jeff Shuren

CDRH Efforts to Accelerate Medtech Regulatory Pathways

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

Related Videos

•  4.2 Regulatory Basics •  FDA •  Jeff Shuren • 

CDRH Efforts to Encourage More U.S.-Based First-in-Human Studies

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

Related Videos

•  4.2 Regulatory Basics •  FDA •  Jeff Shuren • 

Changes to the De Novo Pathway

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

Related Videos

•  4.2 Regulatory Basics •  FDA •  Jeff Shuren • 

Harmonization of Regulatory Standards Across Geographies

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

Related Videos

•  4.2 Regulatory Basics •  FDA •  Jeff Shuren • 

Advice for First-Time Medtech Innovators

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.

Related Videos

•  4.2 Regulatory Basics •  FDA •  Jeff Shuren • 

Overview of FDA’s Guidance for Mobile Medical Applications

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

Related Videos

•  4.2 Regulatory Basics •  FDA •  Jeff Shuren •