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FDA Lax Reviews Cause Thousands of Defective Medical Devices to Be Approved

Each year, the American public sees near countless news stories about dangerous medical devices and defective pharmaceutical drugs hitting the market and causing harm to patients and users. From hip replacement devices to the core temperature regulation systems, there seems to be no end of medical devices that seem good on paper but prove highly dangerous once used.

In response to growing public concerns over the prevalence of defective medical devices, the Food and Drug Administration (FDA) has recently announced it will update its review process for medical products. The FDA has been using the same system for decades. The outdated review procedure could be the root of many defective products being able to reach the public after getting an FDA seal of approval.

The focus of the FDA’s new review system requires medical device manufacturers to base new products on new technologies. In specific, new products should be created with technology no older than 10 years. The underlying idea is that older technologies are automatically less safe compared to newer versions of similar tech. Reportedly about one-in-five medical devices on the market with FDA approvals are based on technology first pioneered more than 10 years ago.

(To learn more about how the FDA will revamp its medical device review process, you can click here to view a full article from Fortune.)

Injured by a Medical Device? You Have Rights!

An important takeaway from the FDA’s decision to change its medical device review process is that it implies its previous methods were ineffective. Feasibly thousands of medical devices on the market today and used by medical providers and patients alike could be inherently defective or prone to failure.

Have you or a loved one been hurt by a dangerous or defective medical device that had an FDA approval all the same? You have a right to seek compensation from any liable party, which will mostly likely include the medical device manufacturer. Call (304) 605-2040 to reach Berthold Law Firm, PLLC and our Charleston product liability attorneys. We have the experience, insight, and strength to stand up to the largest defendants, like Big Pharma companies — and win.

For a free consultation with our law firm, fill out an online contact form now.

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