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FDA issued “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” this week. Group member Glenda Guest included the link at http://bit.ly/split-predicate and began a discussion about it.
Among the changes are guidance on the appropriate use of multiple predicates and determining whether a new device with new indications has a new intended use.
Glenda wrote, “The multiple predicate method of claiming ‘substantial equivalence’ always seemed to me fraught with potential derailment… it complicate[d] the SE process and perhaps contributed to lengthier review cycles.”
Richard Oberreiter replied, “This will complicate the process for many device developers, particularly those creating cutting edge devices outside the PMA world. We would be better off adopting a CE process.”
Ken Kasper notioned whether predicates automatically mean safety and effectiveness anyway. “My concern is our society has no consensus on how to share the risk so we dump all ownership of risk on FDA.”
What do you think of the split predicate ruling?
Will it affect your launch? If so, how will you compensate?
Medical Devices Summit Midwest: October 1-2 (Minneapolis)
This is worth a look: http://medgroup.biz/Summit-Midwest
Our friends at Opal Events write, “Today most medical devices no longer work as stand-alone items. Information platforms are built into medical systems, wireless tools are rapidly evolving, and connectivity and interoperability have increasingly become an integral part of health systems.
Join industry professionals for this year’s Medical Devices Summit Midwest – to share new ideas, promote novel technologies, and foster development strategies. Our discussions will feature the most cutting-edge software and devices on the market, and you’ll learn how they got there and what they’re doing to stay ahead!”
Meet today’s thought leaders and help revolutionize the medical devices industry at http://medgroup.biz/Summit-Midwest
Discussions This Week:
Do you believe Zimmer CEO David Dvorak?
Daniel Kraft video on the future of healthcare
Has 3D printing helped your device design and manufacturing?
Solutions for exporting devices to EU with translated language-specific manuals?
Make it a great week.
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