REGULATORY WATCHCAT De Novo Post-Mortem 5 – What's the Rush?


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De novo devices should have a postmarket “safe harbor” of several years, when they cannot be used as predicates. I’m not just talking about a harbor of commercial safety for the companies that develop them, although there is that. I’m talking about a harbor of postmarket safety for patients as well. If you want to put patient safety at risk, no better way to do it than to take a novel device for which postmarket safety has a degree of uncertainty and use it to start spinning off more devices that are “substantially” equivalent to it, meaning that their safety is also uncertain.

Full comment, CDRH's response, and my comments on the response are attached.


  • De novo Post Mortem 5 What's the Rush.pdf
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