miércoles, 4 de enero de 2017

CDRH Industry: Premarket Notification (510(k)) Submissions for Bone Anchors - Draft Guidance for Industry and FDA Staff

FDA Logo
Today the FDA published the draft guidance, "Premarket Notification (510(k)) Submissions for Bone Anchors."  This document provides recommendations for 510(k) submissions for bone anchor (suture anchor) devices, intended for attachment of soft tissue to bone.
This draft guidance is a reissuance of the April 20, 1996 draft guidance “Guidance Document for Testing Bone Anchor Devices.” FDA is updating the guidance to clarify and provide current thinking on the recommended content for a bone anchor 510(k) submission, including performance testing recommendations and device description. Specifically, this guidance reflects the most current thinking on relevant bench testing methods for bone anchor devices including nitinol and absorbable polymeric bone anchors.
We welcome your comments on this draft guidance for the next 60 days.

No hay comentarios: