On November 8, 2016, FDA-CDRH issued the final guidance Medical Device Reporting for Manufacturers. This guidance replaces the draft issued on July 9, 2013. It supersedes “Medical Device Reporting for Manufacturers” dated March 1997.
The guidance document describes and explains the current regulation in Part 803 that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for device-related adverse events and certain malfunctions.
The guidance document is available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm359566.pdf