is being presented by Robert J. Klepinski, Regulatory Attorney, with Fredrikson & Byron and airs on Thursday, January 19th, 2012. For more details, or to register please visit our site at www.fxconferences.com
Most medical device companies today wish to gather data on product use and performance without being entangled in expensive IDE negotiations. However, recent FDA enforcement actions have brought new scrutiny to post-market studies. FDA has combined accusations of off-label promotion with enforcement against studies collecting data on usage deemed to be outside cleared labeling. So what are device manufacturers to do? Is there still a path available for collecting this important information? This audio conference explores the regulations involved, recent enforcement actions by FDA, the difficulties in ascertaining the scope of indications today, and ways to gather information within the current enforcement environment.
