Critics say the FDA has kowtowed to industry pressure by avoiding substantial changes to a medical device approval process that has taken fire in recent years for allowing dangerous devices onto the market without requiring device manufacturers to conduct rigorous pre-market testing.
This week, the FDA announced that it was making changes to its controversial 510(k) medical device approval process that will streamline the process for Class II lower-risk medical devices, increasing innovation. The changes will also clarify when a medical device manufacturer will have to submit clinical data to get approval, and will require the creation of a new science council to make sure decisions are science-based.
The move appears to fly in the face of a stream of criticism aimed at the process over the last several years by outside experts and congressional investigations, which say that medical devices get through the 510(k) process too easily and rapidly already, often without the necessary clinical data to show that they are safe.
The program only requires that device manufacturers show that the medical devices seeking approval are “substantially equivalent” to a device that has already been approved.
One example of what the FDA has classified as a Class II low-risk medical device are Bard IVC filters, which are implants used to prevent embolism. Last year, the FDA announced that the IVC filters, which were approved through the 510(k) process without any clinical data being submitted, had a tendency to fracture, sending debris into the heart, lungs and other organs of patients. A medical study found that the Bard G2 filter had a 12% failure rate, with most of the fractures sending fragments into the patient’s heart. The Bard Recovery IVC Filter had a failure rate of 16%. The G2 filter was approved because it was substantially equivalent to the Recovery filter, which was also approved because it was considered substantially equivalent to a previous design.
Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health (CFRH) said that the 25 changes the FDA will implement throughout 2011 will make the program smarter, support innovation, prevent jobs from leaving the country, and get life-saving technology to patients more rapidly.
Consumer watchdog group Public Citizen issued a statement following the FDA’s announcement, saying that the FDA is not being forceful enough about improving the safety and effectiveness of new devices. Public Citizen’s health director, Dr. Sidney Wolfe, questioned how the FDA could consider the 510(k) process an avenue for innovation when all of the devices approved were supposed to be substantially equivalent to devices already on the market.
In November, a report published in the British Medical Journal determined that the FDA is currently unable to protect the public from harmful medical devices because it did not have the manpower, budget or authority to do so. The report also suggested that the FDA had been co-opted by medical device manufacturers, political forces and other special interests.
Similarly, in June 2009, a study by the Government Accountability Office (GAO) found significant shortcomings in FDA medical device approval procedures, and a heavy reliance on the 510(k) process. The GAO report identified gaps in the FDA reviewing process, deficiencies in the agency’s postmarket surveillance, and also found that FDA has not kept up with regular inspections of medical device manufacturing facilities. Many devices which should be put through the more stringent premarket approval process are put through the premarket notification process instead, the GAO found.