The Center for Devices and Radiological Health (CDRH) issued a report in November 2012 on improvements to its review and approval procedures for new medical devices. As part of the U.S. Food and Drug Administration (FDA), the CDRH is responsible for medical device safety and quality. The FDA defines “medical devices” as any device designed to either diagnose or treat disease or other conditions, or to alter or affect a bodily structure or function. They may range in complexity from Class I devices, such as dental floss, to Class III devices like pacemakers. The CDRH’s recent report builds on a plan the agency developed in 2011 to streamline and improve the premarket review and approval of medical devices.
Section 510(k) of the Food, Drug, and Cosmetic Act (FD&C Act) requires any person or business who intends to market a medical device designed for human use within the U.S. to submit a Premarket Notification, commonly known as a “510(k),” to the CDRH. The purpose of the 510(k) requirement is to allow the CDRH an opportunity to review the device and confirm that it is at least as safe as similar devices already on the market. Certain Class III medical devices that are entirely new, or otherwise not similar to any other device on the market, must submit to a Premarket Approval (PMA) process, which is more comprehensive because of the lack of existing safety data.
According to the CDRH’s report, entitled “Improvements in Device Review Data,” the agency’s premarket review and approval efficiency declined between 2001 and 2010. This was largely due to budget constraints, high staff turnover, limited training resources, and high workload. A lack of federal funding accounted for much of these issues, but the ever-increasing sophistication of medical devices compounded the problem, according to the CDRH, making it even harder for the agency to keep up with the incoming documentation. The effect of this decrease in efficiency was a significant increase in the time required for approval of new medical devices, along with the possibility of older, less effective or less safe devices remaining in use, posing a possible threat to patient safety.
In 2009, the CDRH began to re-evaluate its procedures for reviewing new medical devices. By January 2011, it had completed its Plan of Action, which would eventually set out thirty-six actions intended to improve premarket review procedures and modernize the agency’s understanding of new and developing medical technologies. The November 2012 report represents the latest step in the Plan of Action, and it claims major progress.
The CDRH has reportedly decreased the average time it takes to decide on PMAs by an average of several days. The backlog of 510(k) and PMA submissions has decreased substantially, but the total number of 510(k)’s received by the agency may have also decreased. Reviewers at the agency are sending fewer requests for additional information to 510(k) and PMA submitters, thus decreasing the amount of review time. Hopefully these changes will also have a positive effect on patient and consumer safety by improving quality control of new medical devices.
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Improvements in Device Review: Results of CDRH’s Plan of Action for Premarket Review of Devices, U.S. Food and Drug Administration, November 2012
Plan of Action for Implementation of 510(k) and Science Recommendations (PDF file), U.S. Food and Drug Administration, January 2011
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Photo credit: By SynCardia Systems, Inc. (Own work) [CC-BY-SA-3.0], via Wikimedia Commons.