CDRH New Update

CDRHNew

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