Rep. Wyden "needlestick" investigation
This article was originally published in The Gray Sheet
Executive Summary
FDA letter to House Energy and Commerce health subcommittee member Ron Wyden (D-Ore.) identifies "resources and the quality of incoming submissions" as the greatest administrative barriers to efficient approval of new needle and sharps technologies. The letter, which responds to a December inquiry from Wyden on FDA's regulation of needle-bearing devices ("The Gray Sheet" Dec. 21, I&W-8), also notes that FDA has "one reviewer handling these devices".