Video Library

Currently Viewing: FDA

Show more
cdrh-accelerate-innovation-e1422915935918

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.

Show more
cdrh-encouraging-first-in-human-us

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.

Show more
diff-about-de-novo-today

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.

Show more
harmonization-across-geographies

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.

Show more
advice-for-first-time-innovators

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.

Show more
overview-fda-mobile-med-guidance

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.

Show more
key-objectives-mobile-fda

Objectives of FDA’s Guidance for Mobile Medical Applications

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

Show more
what-mobile-apps-are-regulated-and-not

Which Mobile Medical Apps Are Regulated?

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

Show more
determining-app-is-regulated

Determining If a Mobile Medical App Is Regulated

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