Must-Do Guidance Development: What's On Tap From Cures, MDUFA IV
US FDA's device center is facing new mandates and commitments to develop guidelines for industry. The guidance-development stipulations in the 21st Century Cures Act and the recent MDUFA IV user-fee agreement are detailed below.
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The US FDA’s latest report on non-regulated health and medical software finds they are not associated with any substantial increase in risks, though the agency admits there may be some underreporting.
The commissioner explained to senators he is trying to go beyond the 21st Century Cures Act to further encourage development of innovative digital devices.
While Congress makes its push to reauthorize US FDA user fees by mid-summer, here are 10 important details from the underlying industry-agency user-fee agreements that medtech firms should know.