“Guidance for the Submission of Premarket Notifications For Radionuclide Dose Calibrators”

This document was issued on November 20, 1998. It indicates that submissions for these devices should have a software section and it references the current FDA software submission guidance “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” to determine what to include in the submission. It does not explicitly identify a level of concern so that is left up to the manufacturer to determine and justify. In addition to this reference it asks for information on Y2K compliance.