510k审评时效指南.pdfVIP

Contains Nonbinding Recommendations FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals Guidance for Industry and Food and Drug Administration Staff Document issued on October 2, 2017. Document originally issued on May 21, 2004. This document supersedes “FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals” issued October 15, 2012. For