is being presented by F. David Rothkopf, President, of MEDIcept and airs on Tuesday, November 22nd, 2011. For more details or to register, please visit our site at www.fxconferences.com
There has been a lot of news lately – both positive and negative – about the FDA’s 510(k) medical device clearance process. FDA, Congress, and many third parties are reviewing the process for efficiency and effectiveness. The FDA has hired many new reviewers, but training has been slow. They have released new guidance documents relating to 510(k) submission components, but they are radically different than the previous interpretation of the requirements.
The result of all this change has been that review times have increased by 65 percent since 2005, and the number of reject decisions – not substantially equivalent, NSE determinations – increased from a historic level of 3.5 percent to 8 percent of 510(k) submissions during the 2010 fiscal year.
This is the new normal. Even if you sent in a submission two years ago, it might not be acceptable now. So what exactly does FDA want to see in your 510(k) submission, and how do medical device manufacturers cope with this new reality?
