Posts Tagged ‘510(k)’
FDA commissions review of the 510(k) process
Monday, October 26, 2009
Very interested to read recently that the FDA has commissioned the US Institute of Medicine (IOM) to review the 510(k) process. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm183497.htm Whilst the review isn’t due to be complete until March 2011 I’ve already seen several articles from industry associations defending the current process. As part of the IOM there will be two public workshops over the next nine months and we’ll comment on the noises coming out of these workshops when we hear them.
