Medical Device Tracking Records

No description.

Category

Compliance and Risk Management

Maintainer

Office of Compliance

Retention Period

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.

Citation

21 C.F.R. 821.60

Disposition Instructions

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