September 30, 2014 — A study published in JAMA Internal Medicine is warning that most low- to moderate-risk medical devices approved by the FDA through the 510(k) process lack publicly-available scientific evidence to verify their safety and effectiveness.
Diana Zuckerman, the study’s lead author and president of the National Center for Health Research in Washington, D.C., said it’s “shocking” how little information is available despite FDA talk about transparency:
“Let the buyer beware before getting an implant in their body, because there may be no evidence the implant is going to benefit them and no study done in case it might harm them.”
The FDA responded by saying they review much more data than is publicly available.
In the last few years, the FDA 510(k) approval process has been blamed for allowing numerous defective medical devices on the market — power morcellators, vaginal mesh, metal-on-metal hip implants, to name a few. The process allows device-makers to introduce new devices without requiring new safety studies so long as the device is “substantially equivalent” to an approved device.
The researchers took a look at implantable devices that were cleared through the 510(k) process between 2008 and 2012, which included 50 new devices and 1,105 previously cleared devices. Only 8 out of 50 (16%) had enough evidence to support the claim of substantial equivalence. Of the 1,105 previously cleared devices, only 3% were supported by publicly available evidence.
The authors specifically criticize the practice of citing more than one predicate device to make a claim of “substantial equivalence.” In addition, there is a lack of sufficient scientific information in publicly available 510(k) summaries.
There is also “significant room for improvement” in post-marketing oversight — for example, tracking post-marketing safety studies and holding companies accountable for failing to follow through with these tests.
The FDA is already taking steps to address some of these concerns. They required 223 safety studies of 158 medical devices between 2005 and 2011 — but only one study led to an action by the FDA other than a change to the label. The FDA is also modernizing its post-marketing surveillance system by requiring a unique code on all medical devices. This should help the FDA address safety issues.
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