Variance Approval to VarsIQ Media

The FDA Center for Devices and Radiological Health granted a variance approval to VarsIQ Media. A variance is an official exemption from specific regulatory requirements that would otherwise apply to the company under FDA's device regulations. The variance approval letter modifies the standard compliance obligations for VarsIQ Media.

VarsIQ Media should maintain the variance approval letter on file and ensure compliance with any conditions specified in the approval. Companies engaging with FDA CDRH on device-related matters should review whether similar variance relief may be available for their operations. Regulatory affairs personnel should document variance approvals as part of their compliance documentation.