In June 2008 FDANews released an article describing CDRH's top priority which according to the article's summary is a "new postmarket initiative." Also according to the summary, postmarket issues "have taken precedence over premarket [issues]" and have garnered "the first-place slot for the center's priorities."1
It is interesting to note however that postmarket initiatives are nothing new--at least not when they are emanating from the desks of CDRH (Center for Devices and Radiological Health). In 2006 and 2007 similar postmarket plans or postmarket emphases were probably designed--or at least discussed--with the purpose of stimulating stumbling medical device designers/manufacturers or frightening those with less-than-worthy intentions. However, 2008 sheds some light on the subject of actual applications that contribute in a significant way to the latest postmarket initiative. The Sentinel Initiative, as it has come to be known, is the initiative that could bring postmarket surveillance to life.
Why a postmarket emphasis?
Some may wonder how CDRH can describe postmarket prerogatives as their top priorities when the FDA has recently placed so much emphasis on premarket topics such as the Quality-by-Design initiative. An online article seems to justify the CDRH's move toward greater involvement in postmarket surveillance as its states the following: "As much as it tries to, the agency [CDRH] can't anticipate every potential problem with a medical product by parsing through clinical trial data, nor can it mandate longer and larger trials for every product, officials said. Instead, it can combat postmarket problems--and inevitably there will be some--by detecting them earlier."2
The Sentinel System: What is It?
According to the FDA's document The Sentinel Initiative: National Strategy for Monitoring Medical Product Safety, the Sentinel Initiative is intended to be a "national electronic safety system capable of tracking the performance of a drug or medical product, beginning with the earliest stages of clinical research through its effects on millions of Americans who use it to treat or to recover from an illness or condition."3
Like any other organization, CDRH understands that even the best of plans are of little use without the right technology. The Sentinel System would certainly be the far-reaching technology required for greater postmarket surveillance throughout the lifecycles of a medical device, but it's hard to imagine such a large-scale system. What would the system do and how would it be created? Although current accomplishments create a solid foundation for the system, the truth is that the system is still just an idea. According to another online article, for instance, "CDRH already is using CMS data although not specifically related to Sentinel's initial launch."4
Though the system is a work in progress, the FDA does have specific goals in mind. According to The Sentinel Initiative document, the Sentinel electronic system "would need to have the capability to draw data from sources like electronic health records and medical claims." The Sentinel system is also intended to "strengthen the ability of the FDA to query other systems quickly and securely" and "support research and epidemiology studies and the Agency's existing risk identification and analysis processes."
The article also states that "One of the six key topics identified for action as part of FDA's Critical Path Initiative is harnessing bioinformatics, and FDA has been working to create a wholly electronic environment for the management of its product information, including safety information. In passing the Food and Drug Administration Amendments Act of 2007, Congress has set the stage for making an electronic safety system a reality."
All of these goals make it evident that CDRH and the FDA will need to seek out a significant number of collaborators to achieve this desired end result of the Sentinel system. According to another FDANews article, the FDA has launched Sentinel as "an initiative designed to transform the agency's postmarket surveillance system through public and private partnerships..." (emphasis added)5
What does this mean for medical device designers and manufacturers?
The truth is that--for now--there isn't much that medical device companies need to be concerned about as long as they comply with current regulations. The new postmarket focus, however, may result in additional postmarket studies supported by the FDAAA's Section 522 (particularly for pediatric products) and IVD product manufacturers may be required to be more conscientious of labeling procedures. But in large part, there isn't a great deal to worry about in terms of required change. According to Thomas Gross, "There won't be more requirements because of the Sentinel effort..."6
Marci Crane is a marketing communication specialist at MasterControl Inc., a global provider of GxP process and document management software solutions for life science companies (www.mastercontrol.com).
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