Devicemakers Wait for Closeouts After Resolving Warning Letters

FDA Commissioner Margaret Hamburg was right when she predicted last year that regulated companies that get warnings would really want a closeout letter. The trouble is that most of them aren’t getting the letters. As of Nov. 5, only 4 percent of drugmakers and 7 percent of devicemakers that had received a warning letter since Hamburg’s new enforcement policy went into effect Sept. 1, 2009, have received a closeout letter. And most of those who got a closeout had a long wait. On average, it took CDRH 179 days to issue a closeout letter after sending a warning letter, and the Center for Drug Evaluation and Research averaged 238 days.
Devices & Diagnostics Letter