From Jeanne Lenzer and Shannon Brownlee in WaPo concerning implantable devices and the FDA:
Although the FDA insists that high-risk devices undergo “stringent” testing to win approval, few actually do. A recent study, for example, found that only 5 percent of the highest-risk implantable cardiac devices were subjected to clinical trials on par with the testing required for drug approval.
In 1976, when medical devices first came under the regulatory control of the FDA, the agency simply grandfathered in all devices that were already on the market. Under this provision, known as the 510(k) pathway, new artificial joints, cataract lens implants and thousands of other devices developed after 1976 can win approval for sale (or “clearance” in FDA parlance) if the product is shown to have “substantial equivalence” to a previously cleared “predicate” device.” Four out of five devices are cleared for sale this way. Of those, at least 95 percent were cleared without clinical studies, according to research by Diana Zuckerman and her colleagues at the National Center for Health Research.
This “predicate” nonsense is especially alarming. Speaking as a software engineer, building a device from the ground-up, and then exempting it from all testing, in particular safety testing, simply because it’s similar to another device, is a sign of sheer madness. It’s a sign of vast incompetence in the FDA, or, more likely, of malevolent influence of the FDA by the industry it’s assigned to regulate. And, in fact, that’s what the article states.
If you’re a candidate for an implantable device, it might be wise to ask the surgeon if the device has been through the rigorous FDA approval scheme and s/he’s read the reports, or if it’s been exempted under the “predicate” protocol. If the latter, request an alternative recommendation of a device which has been fully tested, and that s/he write a letter of reprimand to the FDA, with a copy going to the local newspaper.
It’s a good article. Go read it.
