FDA is responsible for regulating firms that manufacture, repackage, relabel and import medical devices sold in the United States. Not all such products require approval before going on the market. Most are, however, under the regulatory authority of the FDA Quality Systems Regulation in the event of safety-related concerns. 

To get FDA approval, it depends on the type of product you are marketing. The FDA’s approval process has garnered main criticism over the years. Some drugs have safety concerns, they were approved based on the FDA’s determination that the benefits outweighed the potential risks of the drug. On the other hand, just because a drug or device is FDA approved, it does not mean the product is guaranteed to be safe. You can read below to learn what products require FDA approval.

1: Food, beverages, and dietary supplements - FB doesn't approve food, beverages or dietary supplements, or the food facilities don’t require any type of certification or approval before distributing products. New food additives do require FDA approval. If any manufacture uses a new food additive in his product, they need to put the additive through appropriate testing and prove to FDA that the additive is safe.

2: Medical devices - Approval depends on the risk classification of the device. Devices such as dental floss and bandages are subject to the least regulation. Catheters and wheelchairs are examples of class 2 devices that require FDA clearance. These products are under regulatory control that reasonably assures their safety and effectiveness. Implants and life-sustaining devices such as heart valves require FDA Medical Device Quality Management approval.

3: Food ingredients and additives - Food ingredients and additives like and texturisers must be proven to be safe before use. Additives are also anything in the packaging, such as paper, adhesive or plastic, that can intentionally or unintentionally come into the contact with the food. Products that contain unapproved color additives are considered to be adulterated.

4: Labeling - Manufacturers who use FDA’s logo on their product labeling may be subject to civil or criminal liability. Whether their products require FDA approval or not, food facilities, drug establishments, device establishments and cosmetic companies must adhere to FDA’s current good manufacturing practices and extensive labeling requirements. Labeling is approved when the product is approved.

5: Cosmetics products - Cosmetics include makeup, shampoo, hair dyes and hair products, perfumes, moisturizers and soaps do have to be safe for their intended use. However cosmetic companies are not required to register with FDA. It's important to be aware that certain claims made in cosmetic labeling can cause FDA to regulate a cosmetic product as a drug. 

You may be curious to know how FDA enforces its requirements when so many products do not require premarket approval. FDA enforces its requirements through routine facility inspections and randomized shipment.