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FDA’s IV set guidance

This article was originally published in The Gray Sheet

Executive Summary

Agency posts on its Web site Sept. 22 a 1guidance to industry on submitting 510(k)s for intravascular administration sets. The document updates FDA-recognized standards that were included in the now-obsolete 2005 version, and clarifies recommendations for microbial ingress testing. The guideline also includes a section on simulated clinical use testing and supplies a 510(k) submissions checklist for the devices
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