Background: The U.S. Food and Drug Administration (FDA) evaluates medical devices by two main pathways. The more stringent Premarket Approval (PMA) review requires clinical trials, and the Premarket Notification 510(k) process generally exempts devices from clinical trials if they prove to be substantially equivalent to existing devices. We hypothesized that orthopaedic devices are more likely to be cleared through the 510(k) process and thus are more susceptible to being recalled.
Methods: Using the FDA’s public database, we searched for the following: PMA and 510(k) clearances for orthopaedics and non-orthopaedic specialties, including General & Plastic Surgery, Gastroenterology/Urology, Obstetrics/Gynecology, and Ear Nose & Throat, from 1992 to 2012. Additionally, we searched for all device recall events from 2002 to 2012. For the top-twenty recall companies, we calculated the odds ratio that compares the likelihood of recall for 510(k)-approved devices with that for PMA-approved devices.
Results: From 1992 to 2012, the proportion of non-orthopaedic devices cleared via the 510(k) process decreased from 91% to 53%. However, that of orthopaedic devices decreased only from 94% to 88%. Furthermore, we found that from 2002 to 2012, the percentage of recalled devices was 17.8% for 510(k)-cleared devices and 1.6% for PMA-approved devices. When stratified on the basis of recall class, the odds ratios were 3.5 for class-I devices, 13.2 for class-II devices, and 8.5 for class-III devices.
Conclusions: Given that 510(k)-cleared devices were 11.5 times more likely to be recalled than PMA-approved devices, it is concerning that most orthopaedic devices are cleared through the 510(k) process with limited clinical trials data.
Clinical Relevance: When orthopaedic surgeons are considering using a new device clinically in their patients, it is important for them to consider how the new device was approved by the FDA. If the device was approved by the 510(k) pathway, then it may have been approved without additional clinical studies confirming efficacy or safety.
1Department of Orthopaedic Surgery, Beth Israel Deaconess Medical Center, Boston, Massachusetts
2Harvard Medical School, Boston, Massachusetts
3Tufts University School of Medicine, Boston, Massachusetts
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