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Third Party Reviews – Is This the Real Deal?

Orthopaedic device companies with simpler products like arthroscopes, certain bone fixation fasteners and surgical instruments could consider a regulatory route that doesn’t start with FDA and instead utilize the Third Party Review program. The benefits to doing so include speeding time to market and saving time and resources for more complex 510(k) products.

To set the stage, it’s important to understand the history of Premarket Notifications or 510(k)s prior to discussing third party reviews by accredited persons. Before marketing a device, each submitter must receive an order in the form of a letter from FDA, which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the U.S. This order “clears” the device for commercial distribution. The concept is right on target, and the rest of the world is in harmony with the size, shape and distance of the target with similar regulatory gauntlets. It hasn’t been easy for FDA.

When playing this game of professional presence in the medical device industry, performance is sometimes measured using metrics that we would rather not use or, at least, admit to; metrics that become an Achilles heel rather than a measure of continuing success. The Premarket Notification process that sprang up following the 1976 Medical Device Amendments initiative is one such heel that, frankly, has taken on a life of its own over 40 years. We’ve got it, we’ve got it, we’ve got it. We don’t have it! It’s been a thorn because of the diverse players involved with reviews at FDA and in industry. Of course, the variables to deal with when filing the actual submission for review are sometimes overwhelming.

After a search in my files and then on FDA’s website, I drew the following conclusions. FDA has cleared about 141,000 devices using the 510(k) process since 1976. That’s about 3,500 devices per year. In 1976, the average time to get a device cleared was about 38 days. On average, in the new millennium, it has taken about 121 days, and in the 1990s it took about 147 days. Considering the topsy-turvy regulatory history at FDA, this is not shocking. In fact, one might say this is fairly typical. FDA has been under the gun for 40 years to make this process work. And it’s still not working in an efficient and effective manner, considering the big picture.

In recent years, reports such as the Institute of Medicine’s “Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years,” published in 2011, indicate how individuals and organizations have expressed concern that the 510(k) clearance process is neither making safe and effective devices available to patients nor promoting innovation in the medical device industry. Several high-profile mass media reports and consumer protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical device industry and some patients have asserted that the process has become too burdensome, and is delaying the entry of important new medical devices to the market. Enter the Third Party Review program. Not so quick…we’ve got it; we don’t have it!


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