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Medical Device Approval Process


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On Nov. 26, 2018, the Food and Drug Administration (FDA) announced that they plan to overhaul the vetting system that has been used to approve medical devices for release on the market for the past few decades. The action comes on the heels of reports showing how many previously approved devices have caused consumer injuries.

New FDA Approval Process

Once the new process takes effect, a medical device won’t be approved simply because it is similar to a previously approved device. It will instead have to undergo clinical testing and additional scrutiny as if it were a device that’s never been placed in front of them before.

In announcing the revision of the 501(k) medical device vetting system, an FDA spokesperson also admitted that they’d previously approved many products without having a clear understanding of the benefits or risks that they posed.

Once the overhauled system is in place, the FDA will require all manufacturers to use technology that is 10-years-old or less to develop their new devices. Investigators discovered that 20 percent of the products that have injured patients were equipped with technology older than a decade. In addition, the FDA may release a list of devices that were designed using older technology in the upcoming months.

When asked what motivated them to overhaul the vetting of these devices, the spokesperson stated that the FDA is committed to bringing the American people devices that have better capabilities because they’re constructed using better technology. He noted that newer devices that use updated technology generally cause fewer patient injuries.

One poor-performing spinal-cord stimulator model has injured around 80,000 patients since 2008. There are other cases where an individual’s health has declined after they used malfunctioning insulin pumps or metal-hip replacements. If your medical condition has deteriorated as a result of a defective medical device, a Houston attorney can help you understand your legal options for recovery.

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