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Lancet Standardisation

Are there FDA (or any other appropriate oversight agencies) regs for Lancet size or delivery device specifications?

When I bought my Meter kit, it CAME with a Lancet delivery device that I was advisedly steered AWAY from, because the "spring" was more aggressive, and the associated Lancets "created a larger puncture."

I am sure someone will say I'm "over thinking" the topic, and because of that, I ask for your pardon and patience.

I learn by asking. I find comfort, in knowing as much as I can. Perhaps that's why I did so well in my QA career path.

  1. Hi . That seems like a pretty legitimate concern to me. I have read through this, but I found this link to FDA regulations regarding lancets: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=878.4850. I hope this helps. - Lori (Team Member)

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