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Is the FDA’s 510(K) Approval Process a Giant Loophole?


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FDA-ConfirmsDid you know that a large number of medical devices are not required to undergo testing prior to being approved by the FDA? Some devices claiming to be similar to existing products can be approved through the FDA’s controversial 510(K) approval process.

Transvaginal Mesh Update 3/22/12: Multi-national pharmaceutical and biotech giant Johnson & Johnson sold a transvaginal mesh implant for three years before the device was officially approved by the U.S. Food & Drug Administration (FDA). The product, known as the Gynecare Prolift, is currently the subject of more than 550 lawsuits filed on behalf of women who claim it injured them. Click here to learn more.

FDA 510(K) Approval Process Update 2/14/12: House Democrats have overwhelmingly supported the notion that federal health regulators should have the authority to block medical devices that are based on past products with safety issues from entering the market. A bill introduced earlier this month would close the FDA’s controversial 510(k) loophole that lets manufacturers win swift approval for devices like the much-beleaguered transvaginal mesh implants made by Johnson & Johnson and C.R. Bard inc. Click here to learn more.

Has the FDA dropped the ball on medical device monitoring?

Since 1976, all medical devices must be approved by the FDA before they can be legally marketed to the public. It is the fond belief that FDA approval is a ringing endorsement of a product’s safety, a guarantee that the device has been tested and re-tested by professionals. Unfortunately, this belief is far from accurate.

The FDA’s 510(K) approval process requires little safety information and only some information concerning the products’ efficacy. Once approved, the FDA may or may not require additional studies to be performed. Unfortunately, adverse event reporting for devices has never been very good. In fact, most medical devices currently on the market have not been tested rigorously enough to determine the potential for harmful or fatal events.

According to a recent report published in the British Medical Journal, running large scale clinical trials before the FDA approves everything is impractical, which makes the post-marketing monitoring even more important. Post-approval performance is especially vital for devices because they are less likely than drugs to be supported by clinical studies before being placed on the market. According to the report, these studies are not conducted or are “conducted so poorly as to be meaningless.”

Solutions to the Problem

The authors of the British Medical Journal study suggest that manufacturers be required to submit relevant data about their devices and provide a website where they can report when a device has been removed or deactivated. Another recommendation in the report is that the FDA should appoint an independent review board to determine whether adverse outcomes could be due to the product in question.

Injured by a defective device or product? You may have a case.

The Defective Drug & Products Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in these types of lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.

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