Date: December 30, 2015
The following new items were added to the CDRH web pages on December 29, 2015. Previous CDRH New Items can be found on theCDRHNew Page.
- Class I Medical Device Recall: bioMérieux SA Etest® PIP/TAZO/CON-4 PTC 256 – Potential for Test Result Error
- Federal Register: Electroconvulsive Therapy Devices for Class II Intended Uses: Draft Guidance for Industry, Clinicians, and FDA Staff; Availability
- Federal Register: Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2016 Proposed Guidance Development
- Federal Register: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices Intended for Use in Treating Severe Major Depressive Episode in Patients 18 Years of Age and Older Who Are Treatment Resistant or Require a Rapid Response