Date: January 19, 2016
The following new items were added to the CDRH web pages on January 15, 2016. Previous CDRH New Items can be found on theCDRHNew Page.
- Federal Register: Agency Information Collection Activities; Proposed Collection Comment Request; Information To Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements
- Class I Medical Device Recall: Brainlab Cranial Image-Guided Surgery (IGS) System – Navigation Inaccuracy
- Postmarket Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff
- Program Book - Collaborative Approaches for Medical Device and Healthcare Cybersecurity
- Updates to Anaplastic Large Cell Lymphoma (ALCL) webpage