FDA THIRD-PARTY REVIEW WILL GET ANOTHER REVIEW IN HOUSE, COMMERCE COMMITTEE STAFFER PREDICTS; CONGRESSIONAL DEADLINE FOR FDA BILLS IS TIGHT
This article was originally published in The Gray Sheet
Executive Summary
The House Commerce Committee minority staff anticipates problems for the expansion of FDA's third-party review pilot program when the FDA reform effort moves back to the House later this month. "We are going to have a few controversies in the medical device areas. One of them is going to be how we do an expansion of FDA's own third-party" 510(k) review program, House Commerce Committee staffer Kay Holcombe told a Food and Drug Law Institute meeting in Washington, D.C. on Sept. 4.