FDA Rejects Recommendations to Abandon Flawed Medical Device Review System

In recent years there has been a lot of debate over the effectiveness of the Food and Drug Administrations’ medical device review system, i.e., the 501(k) process. Its critics say that the review system is not comprehensive enough and allows for the approval of unsafe medical devices. However, its advocates argue that a quick and easy approval process is necessary to ensure American patients can take advantage of the most advanced medical products available; a more involved review system would only mean more red tape for medical device companies.

In an attempt to find ways to improve its much-debated medical device review system, the FDA sought the advice of a panel of doctors and researchers from the Institute of Medicine (IOM). Over the years, the IOM has made numerous recommendations for improving government programs. However, in the case of the 501(k) process, the IOM’s recommendations were perhaps more severe than the FDA had anticipated. Rather than suggesting various ways the program could be changed, the IOM instead recommended that it be abandoned all together.

In support of its recommendation, the IOM panel stated that the 501(k) approval process was “flawed” and “does not really assess safety and effectiveness.” In order to obtain approval under the 501(k) process>, a medical device manufacturer must show that its medical device is similar to a device that is already on the market. The approval process was created in the 1970s to allow the FDA to quickly grant approval to those products shown to be similar to those already on the market. However, while it was meant as a temporary method to help grandfather in devices that were already in widespread use, the 501(k) process has become the standard for medical device approval.

The result of the speedy approval process can be seen in many medical device recalls. For example, DuPuy’s metal-on-metal hip joints were granted approval under the 501(k) system and have since been shown to be even more dangerous than earlier metal and plastic hip joint devices. Even though the metal-on-metal joints resembled the already approved medical product, the different materials used in each seem to make a bigger difference than originally anticipated. Instances like this support the notion that the FDA needs to place more restrictions on their medical device approval process.

However, in its recommendations for a new review system, the IOM is actually not recommending a drastic increase in premarket testing. Rather, the panel recommends that the FDA institute better tracking of medical device failures and complications. Not only would this be more cost-effective than increasing the premarket testing, but it would also create a system that was responding to real-world concerns and demands. In explaining why it was not recommending more testing prior to FDA approval, the panel stressed that many of the medical devices cleared under the 501(k) system are not inherently unsafe. Therefore, increased efforts would be better utilized in recognizing and responding to those devices that prove to be unsafe in the real world.

It remains to be seen whether the FDA will adopt the IOM panel’s recommendations. Given the recent efforts made by the FDA to revamp its 501(k) system, it seems unlikely that it would completely abandon those efforts. However, it will be holding a public meeting to discuss the IOM’s recommendations. What remains clear though is that the current medical device approval system is not working and that the FDA is working towards addressing the process’s shortcomings.

Chicago’s Kreisman Law Offices has been handling Illinois medical device liability lawsuits for over 35 years, serving those areas in and around Cook County, including Darien, Wilmette, Schaumburg, and Cicero.