510k无菌器械指南.pdfVIP

Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile Guidance for Industry and Food and Drug Administration Staff Document issued on January 21, 2016. The draft of this document was issued on December 12, 2008. As of March 21, 2016, this document supersedes “Updated 510(k) Sterility Review Guidance K90-1” issued August 30, 2002. This guidance has been updated March 16, 2016 to correct an inadvertent editorial chan