Cutaneous monitor final rule
This article was originally published in The Gray Sheet
Executive Summary
Effective Jan.13, cutaneous carbon dioxide and cutaneous oxygen monitors are reclassified from Class II with performance standards into Class II with special controls. The 1Dec. 13 final rule is accompanied by a same-day 2final guidance outlining special controls. FDA received two comments from manufacturers on the guidance. The agency issued the draft in February (3"The Gray Sheet" May 6, 2002, p. 19)...