Chemical indicators
This article was originally published in The Gray Sheet
Executive Summary
Sponsors of 510(k) submissions for chemical indicators should include a section comparing the new device with its predicate on the basis of intended use, design, indicator agent, sterilization method/cycles, endpoints and shelf-life, FDA draft guidance states. Intended for process indicators, chemical integrators and air removal indicators for test packs, the 1chemical indicator guidance outlines 510(k) content and format requirements for the three types of devices...