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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.

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•  4.2 Regulatory Basics •  Bakul Patel •  FDA •