MASSDEVICE ON CALL — Consumer groups are a frequent presence in discussions of medical device regulation, but one relative newcomer may have lost some points in its representation of how the industry operates in its regulatory environment.
Consumers Union, an advocacy arm of Consumer Reports, launched a charge for more stringent FDA oversight of the industry just over a year ago with its Safe Patient Project.
The group has been involved in recent regulatory discussions involving FDA user fees for the medical device industry and clearance status for Aptus Endosystems’ HeliFX endostapling system, but an analysis the group published last week received a stark review from MDDI Online.
In its report, Consumers Union portrayed medical devices as entirely lacking in safety testing, disregarding any studies that weren’t conducted in humans and saying that "for most implants and other high-risk devices brought to market, manufacturers do nothing more than file some paperwork and pay the FDA a user fee of roughly $4,000 to start selling a product that can rack up many millions of dollars in revenue," MDDI reported.
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