is being presented by Robert J. Klepinski, Regulatory Attorney, with Fredrikson & Byron and airs on Thursday, June 2nd, 2011. For more details, or to register please visit our site at www.fxconferences.com
Various tracks are coming together in 2011 which will affect the manner in which 510(k)s and other submissions will be reviewed by FDA. The Institute of Medicine report has been peer-reviewed and is expected to be released shortly. However, the FDA list of intended changes contains several items that are about to change, regardless of IOM recommendation.
For medical device manufacturers, it is a time of expectation and, perhaps, a little trepidation. This audio conference takes a look at what is likely to change, and discusses how best to prepare for this new reality.
