“30-Day Notices and 135-Day PMA Supplements for Manufacturing Method or Process Changes, Guidance for Industry and CDRH”

This document was issued on February 19, 1998. It provides guidance on changes that are suitable for inclusion in 30- day notices and 135-day supplements. It states that any change in manufacturing needed to accomodate a change in device operating software does not qualify for a 30-day notice and reccomends that submissions for such changes be in the form of a 180 day PMA supplement or alternative submission such as a real time PMA supplement or a pilot PMA supplement.