Draft Guidance for Industry, Clinical Laboratories, and Food and Drug Administration Staff on In Vitro Diagnostic Multivariate Index Assays; Reopening of the Comment Period

摘要

The Food and Drug Administration (FDA) is reopening until October 17, 2007, the comment period for "Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays" published in the Federal Register of July 26, 2007 (72 FR 41081). That guidance was a revised version of the original draft, which was published on September 7, 2006, with a 90-day comment period that was extended to 180 days. In addition, FDA held a public meeting on the draft guidance in February 2006. FDA is reopening the comment period on the revised draft to allow sufficient time for stakeholder comment.