Medcon 2023: Shuren Mulls New Pathway For Digital Devices
The head of the US FDA’s Center for Devices and Radiological Health said that an optional new pathway could help the agency regulate the flood of novel devices intended for at-home use. His presentation also touched on MDUFA V implementation, post-pandemic strategy, and CDRH staffing needs.
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In a wide-ranging speech at FDLI’s 2023 annual meeting, CDRH director Jeffrey Shuren pledged to move forward with regulatory action on lab-developed tests and sketched plans for improved regulation of medical apps.
Two regulatory attorneys spoke to Medtech Insight about the most important steps to take before the public health emergency ends, as well as what enforcement tactics they expect to see from the FDA.
The US Food and Drug Administration has rolled out a program designed to speed up the development of innovative medical devices. The Total Product Lifecycle Advisory Program pilot was authorized under MDUFA V.