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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.