Experts Call for End to FDA Fast-Track Medical Device Approval Process

A group of prominent experts has called for an end to the controversial FDA fast-track approval process that allows medical devices to reach the marketed through an accelerated review, as it has been widely abused by the industry and does an ineffective job of ensuring safety.

Last week, the Institute of Medicine (IOM) called for the FDA to end its 510(k) Clearance Process for the approval of medical devices.

The process allows manufacturers to introduce new medical devices by showing that it is similar to previous ones already approved, without conducting rigorous pre-market testing to ensure the product is safe and effective before being approved.

In recent years, a number of experts and agencies have indicated that the 510(k) approval process is broken, and has allowed a number of dangerous and defective products to reach consumers, some of which were subsequently recalled after causing serious injuries and deaths.

The IOM was asked by the FDA to review a list of reforms the agency was considering using to shore up the program to make it more effective in reviewing medical devices. The IOM’s response, in a report released on July 29, indicates that the reviewers, who are part of the National Academies of Science, may consider the program too broken to fix.

“The IOM finds that the current 510(k) process is flawed based on its legislative foundation,” the institute reports. “Rather than continuing to modify the 35-year-old 510(k) process, the IOM concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle.”

According to a letter (pdf) sent by IOM to the FDA, there is no way to transform the program into an effective premarket evaluation system. In its final report, the IOM recommends that the FDA develop a “more rational” medical device approval process. The FDA has said it will put the report up for public comment.

The IOM found that some of the devices used as “substantially equivalent” predecessors to new devices actually predate the current approval system, meaning that in some cases there are medical devices being used that have never gone through federal review.

Some in the medical industry and the FDA have argued that the 510(k) process encourages innovation and to require all devices to go through more exacting review would stifle the creation of new medical devices. However, the IOM found no support for that argument and recommended the FDA task a commission to look into the claim’s veracity.

There is supposed to be postmarket oversight on 510(k) approved devices, but the IOM found “substantial weaknesses” in the FDA’s postmarket surveillance programs as well.

The report echoes concerns raised in April by officials in the Government Accountability Office (GAO), who testified before the U.S. Senate that the use of the program renders the FDA nearly impotent in protecting consumers from potentially dangerous medical devices.

According to the GAO report, there were 3,510 voluntary medical device recalls from 2005 through 2009, averaging more than 700 per year. A study published in February in the Archives of Internal Medicine found that 70% of all medical devices recalled since 2005 received 510(k) approval.    

Many hip implant systems are approved through the 510(k) system. Even though they are supposed to be improved and better than previous devices, they are allowed onto the market through claims that they are substantially equivalent to older models, which were often approved under the same process. Several generations of devices are often approved through the accelerated process, with no strenuous agency testing of how the evolution of the devices may have affected their performance or safety.

In recent years, there have been several examples of dangerous medical devices being used or implanted in thousands of consumers before serious design defects were discovered by the FDA.

A DePuy ASR hip recall was issued last year for a popular metal-on-metal hip implant system, which was found to be prone to failing within a few years of surgery. The hip system was approved through the 510(k) process, and the defective nature of the hip replacement was not discovered until after more than 90,000 devices were sold.

Similar concerns surfaced last year, when the FDA warned that inferior vena cava (IVC) filters, which are implanted to prevent a pulmonary embolism, may be prone to fracturing in the body, sending debris into the heart, lungs and other organs. The Bard G2 IVC filter was approved under the controversial 510(k) premarket approval process, after the FDA deemed them to be substantially equivalent to the Bard Recovery IVC filter. However, the Bard Recovery IVC filter was also approved under the 510(k) process and the only clinical data submitted to FDA on the Bard Recovery filter was data supporting that it could be safely removed. The Bard Recovery filter has now been linked to a 16% failure rate, and the Bard G2 filter has logged a 12% failure rate.

The consumer watchdog group Public Citizen urged the FDA to heed the IOM’s advice, scrap the program and develop something that is more effective in reviewing medical devices before they hit the market in a press release issued the same day as the report.