During a recent interview with reporter Dan Gorenstein of Marketplace, I shared with him that the U.S. Food & Drug Administration approved 15,000 medical devices from 2012-2016, with over 2,900 medical devices approved in 2016 alone (according to EmergoGroup). In researching that statistic, I learned some other fun facts about the FDA approval process.
Did you know that the average medical device approval from the FDA takes an average of 177 days? Neither did I.
Did you know that 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 for review. The next four digits are sequential starting at 0 and indicate the order in which the submission was received during the year.
Did you know that the first 510(K) ever submitted was by Zimmer Inc., which holds K760001, submitted on May 26, 1976.
Did you know that Boston Scientific Scimed Inc. owns K000001? It’s not the first 510(K) ever, but it was the first one submitted in the new millennium on January 3, 2000.
I’m sure 2017 will see it’s share of medical device approval submissions to the FDA and I’m sure we’re going to learn about some incredible technologies to help improve the way home health care is delivered. I’ll try to cover most of it right here, so stay tuned!
Thanks to medical device consultants EmergoGroup for the FDA fun facts.