REAGENTS GUIDANCE EASES 510(k) RULES FOR OEM REAGENTS USED WITH MODIFIED ANALYZERS, SECONDARY REAGENTS FOR MULTIPLE SYSTEMS; EFFECTIVE DATE JUNE 17
This article was originally published in The Gray Sheet
Executive Summary
Premarket notification submission requirements for many in vitro diagnostic reagent manufacturers will be considerably reduced under an FDA guidance that goes into effect June 17. The document, called "Data for Commercialization of Original Equipment Manufacturer, Secondary and Generic Reagents for Automated Analyzers," was released June 10.