MDR Reportable Events

No description.

Category

Compliance and Risk Management

Retention Period

Retain for ten years after date of event then dispose of.

Citations

21 C.F.R. 803.18; O.C.G.A. 51-1-11

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