Date: August 19, 2015
The following new items were added to the CDRH web pages on August 18, 2015. Previous CDRH New Items can be found on theCDRHNew Page.
- Class II Special Controls Guideline: Nucleic Acid Amplification Assays for the Detection of Trichomonas vaginalis - Guideline for Industry and Food and Drug Administration Staff
- Federal Register: Medical Devices; Cardiovascular Devices; Classification of the Esophageal Thermal Regulation Device
- Federal Register: Pilot Program for Medical Device Reporting on Malfunctions
- Federal Register: Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems; Guidance for Industry and Food and Drug Administration Staff; Availability
- Class I Medical Device Recall: Western/Scott Fetzer Company OxyTOTE Portable Oxygen Unit May Ignite and Burst