Liquid chemical sterilants/high level disinfectants
This article was originally published in The Gray Sheet
Executive Summary
Guidance issued Jan. 3 on submission of 510(k)s for germicides and other disinfectants requires applicants to perform testing to show compatibility with specific materials and devices. "FDA encourages the germicide 510(k) sponsor to work with reusable device manufacturers to evaluate the effect of repeated use of the germicide on device functionality," the guidance states. Document supersedes previous guidance on the subject issued in December 1997