Medical Device Tracking Records
Retain records for the useful life of each tracked device manufacture or distribute then dispose of. The useful life of a device is the time a device is in use or in distribution for use.
21 C.F.R. 821.60
Confidential destruction is required. Paper must be shredded, pulped, or incinerated; electronic records must be overwritten or the storage media physically destroyed. Deletion of information in computer files or on electronic storage media is not sufficient.
Last Updated: December 31, 2008