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What Does FDA Approval Mean for Medical Devices

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What Does FDA Approval Mean for Medical Devices

When using medical devices, you want to be sure the equipment you’re using is safe. Because this equipment is often used in life and death situations, you’ll likely check to make sure it has been approved and judged safe. In this respect, you’ll discover medical equipment has undergone FDA testing and approval. However, what does FDA approval truly mean? Also, what to do if you have an FDA approved product that is harmful.

Safety Classifications

The FDA regulates not only food and medicine safety, but medical device safety as well. When a product is approved by the FDA, it has met a minimum requirement for product safety. There are two levels of classification a product can receive from the FDA. When a product clears review it receives a premarket modification. This notification is also known as a 510(k). For products receiving a 510(k) to be approved for public release, it must be equivalent in use and application to an existing product already approved for sale.

Products that submit a PMA (Premarket Approval) form are reviewed and are listed as approved if they meet the FDA requirements. Unlike 510(k) approvals, a PMA needs to only prove its effectiveness in its stated purpose and be safe for consumer use. These types of classifications are applied to more risky items that are considered Class III by the FDA.

Class I, II & III

Upon release to the market, you’ll find your medical devices will have a classification level. This classification is listed as Class I, Class II, or Class III. These classes increase on the basis of safety. A Class I device is, for example, considered very low risk. A Class I device you may have in your home is a tooth brush. A Class II device will have a higher risk involved in its common use. An example, as per the FDA, would be condoms. Class II devices therefore, have a higher standard of safety usage and regulation. Class III items are very risky and because of this are highly regulated. Unlike lower classes, Class III items have to be approved by the FDA before being marketed to the public. For example, you might have a Class III item in your body if you have received a replacement valve during heart surgery.

From a legal perspective, when you are filing a lawsuit concerning FDA approved medical devices you may face increased legal difficulties. The US Supreme Court ruled in February 2008 that the 1976 Medical Device Amendments blocks state lawsuits that directly challenge the safety of an FDA market approved device. Now you should know that does not make a lawsuit impossible. It simply means you need a lawyer experienced in product liability laws to prove fault under the law. For those of you seeking to simply report a faulty product the FDA does take reports. The Medwatch website is used for just such cases. This online reporting form can be used for not only medical devices but also foods, medicines, supplements, and cosmetics.

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