CDRH In 2012: More Pilots, Guidances And Regs
This article was originally published in The Gray Sheet
Executive Summary
The device center plans to finalize all the 510(k) program guidances it issued last year, among a boatload of 2012 priorities. Many of this year's top goals spring from the 510(k) and “science in regulatory decision making” reform programs that commanded attention in 2011.