Announcing Final Guidance Document: “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile” – Webinar February 11, 2016
Today, the U.S. Food and Drug Administration issued final guidance document, “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile” . Its recommendations seek to…