FDA CDRH issued: “Class II SPecial Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information” on Dec 10, 2004.

This guidance mentions software in its table of risks and in section 4.C. where it refere readers to the general software submssion guidance and the GPSV. The guidance states that if you adhere to the guidance (and its referenced guidances ) then no 510(k) would be required.