510(k) Reform – What Does it Mean? An American Perspective on an International Challenge

February 22, 2011

By Sparta Editorial


It seems that we’ve been bombarded lately with news about the 510(k) process, which for the device industry is a critical part of innovation as it allows abbreviated reviews for devices based on previous generations, known as predicate devices. What works? What doesn’t? There is quite a lot of discussion, with  polar-opposite perspectives of each side.  At its core, the debate is centered around determining the appropriate balance of availability of innovative new products vs. ensuring robust clinical data demonstrating device safety. Classic risk vs. reward.  As you can imagine, there is a camp that wants faster approvals and points to the fact that devices are approved much faster in Europe than they are in the US, a cause recently taken up on Capitol Hill http://www.massdevice.com/news/house-probes-why-medical-devices-take-longer-hit-us-market.   Business leaders and politicians have argued that the American economy is at risk of shedding jobs based on an overly restrictive approval process – or worse yet, could be jeopardizing public safety by not approving the new products as quickly as some other countries http://www.foxnews.com/health/2011/02/18/fda-criticized-device-approvals/#. Clearly patients also want access to the latest and greatest technology and struggle to understand why something they believe might help them isn’t available for use in this country, even though the product is made in this country.

 On the other side you have groups that think the FDA is too liberal in their oversight of device manufacturing and link this to increased risk for patients.  A recent study by the Archives of Internal Medicine http://archinte.ama-assn.org/cgi/content/full/archinternmed.2011.30  showed that of the 113 Class I (highest risk) recalls from 2005 to 2009, 80 of them (71%) were approved via the 510(k) process.  It also goes without saying after the public backlash associated with recent high-profile recalls that the American public clearly does not accept recalls as part of the manufacturing process of devices or drugs.  On one hand patients demand the highest quality yet still yearn for access to the latest technology – and sometimes the balance is off and one is improved at the expense of the other.

This debate will continue as the FDA, lawmakers, doctors, patients and industry work to influence the future of the 510(k) process.  It’s unknown where the new lines will be drawn but we do know that the FDA has announced 25 changes it wants to start implementing now and reserves the right to make additional, and more far-reaching changes after the IOM report comes back later this summer. 

A great resource to monitor what’s happening is the CDRH 510(k) link http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm239448.htm.   There is also an informative article about the new “Innovation Pathway” approval mechanism and the first product that will use it, a bionic arm designed by the military http://healthland.time.com/2011/02/11/coming-soon-the-100-million-dollar-robotic-arm/.

 Hang tight, I think we’re in for more change in the coming months!

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