#40 – Breakpoints Talks Breakpoints: Microbiology Labs and Stewardship
Breakpoints
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The Challenges of Susceptibility Test Device Updates
I think the challenge is that susceptibility test devices are 510 K cleared, which means once you get it on the market, you're done. The FDA really doesn't have any mechanism to get manufacturers to update or to have a timeline for those updates. It's kind of like this catch 22 where you don't have a good process to get them updated routinely. But you also don't want to make it so hard to get new drugs added to these panels. I'm not going to say people have to use seal a style. A little bias on that regard.
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