FDA Embraces Total-Time Pre-Market Review Goals, With Shared Accountability
This article was originally published in The Gray Sheet
Executive SummaryFDA negotiators have warmed to the idea of total-time performance goals for the next round of medical device user fees, beginning in 2012, as long as FDA and industry share accountability for the time it takes to review new products.
You may also be interested in...
The agency outlined how it plans to calculate review times and meet performance goals for PMA and 510(k) submissions in two recent guidance documents.
The tentative agreement of $595 million in user fees over five years is more than companies had wanted to spend. But industry negotiators insist it is a good deal, tied to performance goals and process improvements they say will ensure greater speed and predictability in reaching the U.S. market.
The latest on user fee negotiations and other device regulatory issues.