Chronimed
This article was originally published in The Gray Sheet
Executive Summary
Select GT blood glucose monitor warning letter response filed with FDA March 22 addresses agency concerns "satisfactorily," FDA says in an April 23 follow-up letter. The agency issued the warning letter March 3, citing the device for lack of 510(k) clearance ("The Gray Sheet" March 29, p. 20). However, the agency appears satisfied with the firm's response that the device was covered under a "note-to-file" provision in the firm's February 1997 510(k) for its Supreme II monitor. The agency plans to confirm adequacy of the company's corrective action plan during a routine audit shortly