FDA Variance Approval Letter to Mykyta Sukhenko

The FDA's Center for Devices and Radiological Health (CDRH) has issued a variance approval letter to an individual named Mykyta Sukhenko. The specific details of the variance are not publicly available due to restrictions on personally identifiable information, though a redacted version of the letter has been provided.

This document represents an individual approval for a specific variance request. Regulated entities seeking similar variances should consult the FDA's guidance on the variance process. No immediate compliance actions are required for other entities based on this individual approval, but it may serve as an example of FDA's decision-making in such cases.