Variance Approval Letter for Shane Parker

FDA CDRH approved a variance request from Shane Parker, granting regulatory relief from standard CDRH requirements under docket FDA-2025-V-5013. The variance represents a formal exemption or deviation from applicable medical device regulations.\n\nAffected parties should review the variance terms to understand any conditions, limitations, or reporting requirements imposed. While the variance is binding on the recipient, it does not create new obligations for other entities in the medical device industry. Entities with similar regulatory needs should consult FDA's variance procedures for potential separate applications.