Date: August 5, 2015
The following new items were added to the CDRH web pages on August 4, 2015. Previous CDRH New Items can be found on theCDRHNew Page.
- Federal Register: Medical Devices; Ear, Nose, and Throat Devices; Classification of the External Upper Esophageal Sphincter Compression Device
- Federal Register: Medical Devices; Immunology and Microbiology Devices; Classification of Trichomonas Vaginalis Nucleic Acid Assay
- Refuse to Accept Policy for 510(k)s - Guidance for Industry and Food and Drug Administration Staff
- Supplemental Measures to Enhance Duodenoscope Reprocessing: FDA Safety Communication
- Updated: Reprocessing of Reusable Medical Devices