FDA, or the Food and Drug Administration, is a federal institution in the US that is responsible for protecting its citizens from any major health problems that can occur either from poor medication or bad equipment used in surgery. Basically, the FDA are the ones to either approve a new equipment or drug that is going to be available on the market. There are two types of clearance that you can get from FDA. One is for new products (FDA-approved) and the other is for a drug or equipment that is similar to an old one and can be considered as a replacement (FDA-cleared).
The FDA classified implants in 1976 as Class II. This means that any type of implants need to pass a general control and a special control before allowing them to be used in the US.
In 1988, implants were moved in Class III. With Class III, implants now need premarket approval as well. A class category is assigned to any device depending on its purpose and use. When placing a product in a certain class, the manufacturer needs to fill in a special form, known as a 510k form. Along with this, the manufacturer needs to supply information about the product, such as materials used for building it, its purpose, technological characteristics, and performance data. After filling these documents, a class is assigned as follows:
● Class I – Devices are subject to a comprehensive set of regulatory authorities called general controls that apply to all classes of devices.
● Class II – Devices for which general controls are insufficient to provide reasonable assurance of the safety and effectiveness of the device, but have sufficient information to establish special controls in order to provide such assurance.
● Class III – Devices for which general controls are insufficient, and there is insufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device. The product will require premarket approval.
FDA banned one of the most used implants available in the US until 2010, which is the composite filler implant. All types of implants are available to be checked on the FDA website. While choosing the right one for you, you can also check if the one that you choose is FDA approved. Get as many information as you can from your plastic surgeon so you will know if you are in safe hands and all the devices or implants are used accordingly. Also ask for certifications before surgery, especially from the ABCS (American Board of Cosmetic Surgery). The main purpose of ABCS is to award certification for surgeons that are with the highest standards in cosmetic surgery. They will train and test a surgeon, and you will definitely get the best treatment around.
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