DEVICE USER FEE LETTER AGREEMENT INCLUDES GUIDANCE DOCUMENTS
This article was originally published in The Gray Sheet
Executive Summary
DEVICE USER FEE LETTER AGREEMENT INCLUDES GUIDANCE DOCUMENTS that the agency commits to develop. Signed July 8 by FDA Commissioner David Kessler, the letter spells out performance goals that the agency agrees to meet after enactment of a device user fee bill. The letter, which will accompany user fee legislation expected to be introduced the week of July 11, was sent to Reps. John Dingell (D-Mich.), Henry Waxman (D-Calif.), Carlos Moorhead (R-Calif.) and Thomas Bliley (R-Va.).