It’s gratifying that four months after “The Bleeding Edge” exposed the flawed U.S. medical device approval process the FDA has announced regulatory changes to rely on more modern predicate devices or “objective performance criteria” for device approval. This is a small step in the right direction, but the most dangerous loophole remains: the 510(k) process.
The problem with the 510(k) process is that it allows high-risk devices to be implanted in people without first undergoing human clinical trials. Until all devices are properly tested in clinical trials before being sold, hundreds of thousands of Americans will continue to be guinea pigs for industry and be unnecessarily injured and killed each year.
Additionally, the FDA’s definition of high-risk is grossly inaccurate. Devices like mesh, joint replacements, and robotic surgery system were defined as “moderate risk” by the FDA, and passed through the 510(k) process. The truth is all those devices, which we profiled in “The Bleeding Edge,” have caused egregious harm and in many cases, death.
The vast majority of dangerous medical devices that have been marketed have been cleared through the 510(k) loophole. For decades the FDA has utilized the 510K process to approve dangerous devices based on predicates—such as metal-on-metal hips—even if that predicate had previously been removed from the market because it had failed. But the FDA continues to say that they still “firmly believe in the merits of the 510(k) process”, even after an extensive 2011 analysis by the Insitute of Medicine concluded that there is no criteria for safety and effectiveness in the 510(k) process, there is no way the process could be “more safe and effective”.
With this announcement, it is unclear who will make this criterion, and brings to question why the FDA defends its flawed 510(k) process. It is certain that this faster, cheaper process t pleases the medical device industry, which funds the FDA.
Instead of making vague promises, we urge the FDA to close the 510(k) loophole once and for all.