July 11, 2012

MDUFA III - The Summer Sequel

Hollywood is all about summer block busters. Often these are remakes or spinoffs. So Batman Rises again, Spiderman get a new look and there are More Men are in Black. A less well know franchise just inked a renewal. Even more surprising is the group who produced it - Congress. It is called MDUFA III. It is a sequel. 

You may not be very familiar with MDUFA. I mistakenly call it Mustafa or Medusa regularly. It isn’t a Lion King or a monster of myth with snakes for hair. MDUFA is DC speak for Medical Device User Fee Amendment is part of the regulations that fund and manage the FDA. Some wags may content that means it is a scary monarchical monster but is isn’t.

If you live with a chronic condition that is managed with medical devices you should probably know a little about MDUFA. It started in 2002. (1) It allows for industry to pay fees that fund the FDA. These fees help pay for the review of medical devices. These fees were a means of preventing a backlog of device and drug approvals by funding FDA staff to review applications. 
The review that was just signed into law also creates performance goals for the FDA review process with outside third party review of the FDA’s pre-market approval (PMA) process, meeting these goals. The goal are: 
  • For submissions received in FY 2013, FDA will issue a MDUFA decision for 91% of 510(k) submissions within 90 FDA Days.
  • For submissions received in FY 2014, FDA will issue a MDUFA decision for 93% of 510(k) submissions within 90 FDA Days.
  • For submissions received in FY 2015 through FY 2017, FDA 
To put that into a diabetes perspective the International Organization for Standardization (ISO) 15197 standard that specifies that, for a blood glucose level of below 75 mg/dl, the monitor reading must be within 15 mg/dl of the reference reading and, for readings of 75 mg/dl or higher, the monitor reading must be within 20% of the reference reading in 95% of tests. (2) So starting in October 2012 the FDA will ave tighter response time goals that our meters have accuracy goal. Yes I know that is a bogus comparison but what matters is there are goals to turn around device applications. Those goals get tighter with time. 

I will concede that MDUFA is not as exciting as a summer action movie and it may take longer to read the entire legislation than a film takes to watch. That said I am happy to see this action taken by Congress before the summer is over and election year politicking get in the way of progress. 


(2) International Organization for Standardization. In vitro diagnostic test systems—requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. 2010. Mar 20, ISO 15197:2003. http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=26309 Accessed.


  1. My fear is that it will be easier to select 'Not Approved' in the newly allotted time period than it is to get approval in a longer time period.

  2. While the stated goal of the user fees appear logical, these can be interpreted in perverse ways. Under former FDA chief Andrew von Eschenbach, for example, the fees which fund the reviewers were interpreted to mean that the FDA served the very industries the agency supposedly regulates, not necessarily to protect the public's food and health. Having said this, fees do ensure the FDA has the internal resources necessary to review applications and enforce rules, but the agency should never forget that it works for U.S. taxpayers, NOT pharma or medical device companies!

  3. Fair points Mark & Scott. I hope third party review can help sniff out both. Failing to renew MDUFA would have med things significantly worse. In the current climate fees are seen as taxes and the vote for no tax mentality of some gave rise to fears that this may not have passed.

  4. You guys are way smart. I can't even begin to scratch into an understanding of what to hope for re this legislation. I'm stuck on this: a 75 might equally likely be a 90 or a 60?!

  5. Thanks for this, Bennet. I hope that the fee changes will ensure (as Strumello notes) the adequate review resources needed. Maybe some of that will involve a more specific patient response mechanism or platform... who knows. Aside from that: Help me understand something that's going over my head.... Is this specifically influential on ISO 15197, or was that just an example? Is that standard still being proposed for change at this time (sorry if that's a tad off topic...)? Anyhow, whether this is summer movie blockbuster caliber or not, it's something that could very well be a blockbuster impact on us PWDs and device costs down the road. So well worth the screening!

  6. Hey Mike

    The Meter bit was a just a device I was playing with to write and to bring the meter accuracy issue into the fringes of the conversation. There is no direct link between MDUFA III and meter accuracy that I am aware of. (Not that my awareness is all that broad.)

  7. Katy -

    Isn't that disturbing? The one thing that we use to manage all of our other diabetes tools does not even have to be accurate?!