RE:Next Steps...File appeal with FDA citing 2013 AUA-FDA guidance. FDA responds in 30 days. Reviewed by supervisor of person who made decision. Decision is highly unlikely to be overturned, but worth the effort. https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ContactCDER/ucm444092.htm