Date: June 19, 2015
The following new items were added to the CDRH web pages on June 18, 2015. Previous CDRH New Items can be found on theCDRHNew Page.
- Federal Register: Factors To Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions; Draft Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators, and Food and Drug Administration Staff; Availability
- Federal Register: Non-Microbial Biomarkers of Infection for In Vitro Diagnostic Device Use; Public Workshop; Request for Comments
- Consumer Information on: Radiesse Injectable Implant - P050052S049
- Summary Information for: Superion InterSpinous Spacer
- Consumer Information on: Superion InterSpinous Spacer - P140004