Device warning letter pilot
This article was originally published in The Gray Sheet
Executive Summary
FDA's18-month pilot program for certain warning letters related to quality systems violations and 510(k) and labeling violations will begin March 29, according to a March 8 Federal Register notice. If FDA finds deficiencies that warrant a warning letter, the agency will first give the manufacturer 15 days to respond. If the written response is acceptable, no warning letter will be issued ("The Gray Sheet" Aug. 31, 1998, p. 20)