SSGI corrective action plan on premarket data integrity to be submitted to FDA within one month.
This article was originally published in The Gray Sheet
Executive Summary
SSGI TO SUBMIT CORRECTIVE PLAN FOR 510(k) DATA INTEGRITY DEFICIENCIES within one month, Chico, California-based Small Systems Group, Inc. says. The plan, which is required under FDA's application integrity policy (AIP), will outline steps the company will take to ensure the integrity of data in its premarket submissions to FDA. The agency placed SSGI under its AIP in July 1994 due to concerns about data in a May 1993 submission for the firm's Prowess 2000 software package for radiation therapy planning.