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.
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.
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.
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.
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.
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.
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.
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.
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.