510(k) Process Changes Survival Guide Practical Answers in 90 Minutes


On Dec. 27, 2011, the FDA gave the industry a belated holiday gift: A series of guidances intended to put to rest the controversy regarding 510(k)-related clearances. But has it succeeded? The jury is still out. Many are still wondering about that footnote that appears to have scraped the use of “split predicates.” And is it possible to defy long-held beliefs and use more than 5 predicates?


Audio CD/Transcript - April 19, 2012 The Audio CD/Transcript will be shipped the week of May 14, 2012.