Information disclosure
This article was originally published in The Gray Sheet
Executive Summary
Combination device/biologic products are subject to disclosure procedures outlined in Feb. 15 Center for Biologics Evaluation and Research draft guidance on information disclosure and preparation of applications for products subject to CBER open advisory committee meetings after June 1, 2001. Premarket approval applications and 510(k)s for non-combination products are not subject to the disclosure procedures, guidance states