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Is It Really FDA Approved?

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FDA uses a risk-based, tiered approach for regulating medical devices.

FDA classifies devices according to risk. Only the highest-risk devices, such as mechanical heart valves and implantable infusion pumps, require FDA approval before marketing. To receive FDA approval for these devices, the manufacturer must demonstrate that its devices provide a reasonable assurance of safety and effectiveness.

Moderate-risk medical devices (e.g., dialysis equipment and many types of catheters) are cleared for marketing based on an FDA determination that they are substantially equivalent to an already legally marketed device of the same type.

FDA has exempted certain low-risk medical devices (e.g., certain bandages) from premarket review when they are for the same use and of the same technology.

FDA approves additives in food for people.

FDA field investigators inspect food companies, examine food shipments from abroad, and collect samples. Laboratory scientists analyze samples. Compliance officers recommend legal action and follow through on enforcement issues. What undergoes premarket approval? New food additives and color additives must be approved before they can be used in foods. These additives are considered food under the law.

New food additives, including substances added intentionally to food and substances that may migrate to food because they contact food (e.g., food packaging) must be shown to be safe to FDA's satisfaction before companies can market them.

Companies that want to add new additives to food bear the responsibility of providing FDA with information demonstrating that the additives are safe. FDA experts review the results of appropriate tests done by companies to ensure that the additive is safe for its intended use.

An approved food additive must be used in compliance with its approved uses, specifications, and restrictions. Certain food ingredients, such as those with a long history of safe use in food, do not require premarket approval.

FDA approves drugs and additives in food for animals.

FDA is responsible for approving drugs and food additives given to, or used on, over one hundred million pets, plus millions of poultry, cattle, swine, and minor animal species. (Minor animal species include animals other than cattle, swine, chickens, turkeys, horses, dogs, and cats.)

FDA does not approve pet food, but rather approves the food additives that are used in pet food. FDA has the authority to take action against pet food products that are in violation of the law.