Earlier this week, we talked about the loophole in the U.S. Food and Drug Administration’s 510(k) medical device approval process which reportedly allowed for the approval of a vaginal mesh product manufactured by New Jersey-based Johnson & Johnson. Recently, members of the U.S. House of Representatives proposed a bill which, if passed, would close that loophole, effectively preventing devices based on dangerous, previously-recalled medical products from being approved by the FDA.
According to Jeffrey Shuren, the director of the FDA Center for Devices and Radiological Health, the agency does not necessarily support the bill itself, but it does support some change to the approval procedure. “It’s good for patients and it’s good for companies,” he said, “and it assures that if there’s a problem with the new device, it gets addressed before it goes to market.”
Under the current approval process, Shuren says, a problem with a device can easily get replicated through endless future generations of the product.
The bill has naturally been opposed by a trade group that represents the device industry. The group says that the bill would add additional regulatory burdens for manufacturers that already struggle with a tedious FDA approval process.
In response, Shuren says that the change may actually make approvals easier when new devices are similar to previously-approved devices that have since been the target of recalls or safety concerns. In such a situation, manufacturers could show how their device had corrected the flaws of past versions, or how the earlier concerns were not relevant to the new version.
We will continue to update our blog as this bill progresses through the legislature.
If you or a loved one has been injured by a defective or dangerous product that has been approved by the FDA, please contact Breslin & Breslin for a free consultation.
Source: Bloomberg, “Medical Device Loophole Needs Closing by Congress, FDA Device Chief Says,” Alex Nussbaum, Feb. 28, 2012