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GAO Report Criticizes FDA on 510k Process

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

The Government Accountability Office (GAO) recently released its evaluation on how the FDA has responded to the GAO’s 2009 findings on the shortcomings of the FDA’s premarket review process for medical devices. The original report found that the review process was not sufficiently vetting medicals devices before they were entering the market. The result of this has been hundreds of recalls and tens of thousands of people suffering from defective medical devices.

At the center of the debate is the 510k process of medical device review. To get a medical device approved through this process essentially all a company needs to do is prove that their new device is “substantially equivalent” to a device that is already on the market and doesn’t need to go through the much more rigorous Premarket Approval process.

Just this past year tens of thousands of hip implant and knee implant devices that had undergone the FDA ‘s 510k approval process were recalled after the devices were shown to have a extremely high failure rate.

If you have been injured as a result of a faulty medical device, contact the attorneys at Rheingold Giuffra Ruffo Plotkin & Hellman LLP to speak with an experienced medical device attorney.

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