FDA’s latest ASR guidance document creates more confusion and raises legal issues

In September 2006, FDA issued a draft document, “Guidance for Industry and FDA Staff-Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions.” Even though FDA issued the final guidance document one year later, its release has not ended the controversy over how ASRs should be regulated.¹

This article summarizes some of the substantive elements of the final ASR guidance document and their impact. The article also discusses some of the procedural issues that have emerged.

^1. “Guidance for Industry and FDA Staff-Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions,” FDA (Rockville, MD: 2007 [cited 22 February 2008]); available from Internet: www.fda.gov/cdrh/oivd/guidance/1590.pdf

Additional information available here.