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Goldman Law Offices

The Food and Drug Administration's role in medical devices

No one, including injury attorneys, would ever claim that medical devices are always a risk. In fact, some of these devices prolong the lives of millions and improve the quality of life for millions more. However, many of these devices do harm patients in Pennsylvania and elsewhere, resulting in product liability lawsuits.

Before most medical devices ever reach the public, the Food and Drug Administration (FDA) must either approve or clear the device. Patients expecting to use such a device should understand that there is a difference between FDA-cleared and FDA-approved. Knowing the difference ensures that you are fully informed about the device before you consent to its use. Below, we have provided brief definitions of the two terms for you to consider.

FDA-cleared

This means that the device in question is "substantially equivalent" to a similar medical device that is already in use by the public. As such, the FDA may not review or test the product thoroughly. If it turns out that the device is not as safe as the FDA indicated, patients may suffer injury.

FDA-approved

Devices that pose a high risk of patient harm must undergo an exhaustive review by the FDA. Once the review is complete, and the FDA understands the injury risks for consumers, it may or may not approve the device for use. If using the device gives very ill patients the chance to live longer or feel significantly better, the FDA will probably approve the device despite its risks.

We encourage all patients prescribed a medical device to research its background before consenting to its use. This can help on two fronts. First, you will have a better understanding of the product's known risks. Second, if you do suffer an injury from the device, knowing its review and clearance history can support your case if you choose to file a product liability claim.

Please continue reading our website resources to learn more about unsafe products.

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Goldman Law Offices

90 E. State Street
Doylestown, PA 18901

Phone: 215-348-2605
Fax: 215-348-5247
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