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Little Known Facts About FDA's 510(k) Process

Posted 15 January 2015 | By Chris Schorre

Little Known Facts About FDA's 510(k) Process

Content provided by Emergo, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide.

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 ...

  • FDA has cleared more than 140,000 devices via the 510(k) program since 1976
  • FDA usually clears about 3,000 devices each year, -+ 10%
  • Back when the 510(k) program started in 1976, the average time to get a device cleared was about 38 days. Not anymore. Sigh …
  • The longest ever time to get 510(k) clearance was for three submissions filed by the same company at the same time in late 1998. Those devices cleared in early 2007 – a whopping 3,037 days (8.3 years) later.

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 26 May 1976. Boston Scientific Scimed Inc. is the proud owner of K00001. No, it's not the first 510(k) ever, but it was the first one submitted in the new millennium on 3 January 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 its 510(k) numbering scheme in 2076 but there’s plenty of time to start planning … even for a government agency.


Read the original post on Emergo's website

Tags: Emergo, 510(k)

Categories: Regulatory News

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