FDA Variance Application from Mykyta Sukhenko

The FDA has made publicly available a variance application submitted by Mykyta Sukhenko, identified by docket number FDA-2026-V-1610-0001. While the full application contains restricted personally identifiable information, a redacted version has also been provided. The application was authored by CDRH (Center for Devices and Radiological Health).

This filing is primarily informational. Regulated entities should note the existence of this variance application and may review the redacted version if interested in the specific details or the nature of the variance sought. No immediate action is required from compliance officers based on this notice, as it pertains to a specific applicant's request.