Date: January 3, 2017
The following new items were added to the CDRH web pages on December 30, 2016. Previous CDRH New Items can be found on the CDRHNew Page.
- Federal Register: Medical Device Accessories--Describing Accessories and Classification Pathway for New Accessory Types; Guidance for Industry and Food and Drug Administration Staff; Availability
- Federal Register: Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems
- Premarket Notification (510(k)) Submissions for Bone Anchors - Draft Guidance for Industry and Food and Drug Administration Staff