2015年 1月 13日
In February, Emergo will release its annual analysis of FDA 510(k) review times for 2014 and prior years. During our analysis, we uncovered some interesting facts (at least to RA professionals) we wanted to share.
For instance, did you know...
And finally…
All 510(k) submissions are assigned a “K number” – the letter K followed by six digits. The first two digits of the 510(k) number indicate the year it was submitted to FDA for review. The next four digits are sequential starting at 0 and indicate the order in which the submission was received during the year. The first 510(k) ever was submitted by Zimmer Inc. which holds K760001, submitted on May 26, 1976. Boston Scientific Scimed Inc. is the proud owner of K000001. No, it's not the first 510(k) ever, but it was the first one submitted in the new millennium on January 3, 2000! Many others were submitted that same day but theirs made it to the top of the pile.
Not sure what the FDA plans to do about their 510(k) numbering scheme in 2076 but there’s plenty of time to start planning…even for a government agency. :-)