The relevant FDA regulations which require that manufacturers, processors and packagers of drugs, medical devices and some food products take steps to ensure that their products are safe, pure and effective are contained in the Code of Federal Regulations.

The FDA Code of Federal Regulations Title 21 is a set of regulations issued by the United States Food and Drug Administration (FDA) that pertain to the production, testing, labeling, and sale of food, drugs, and other related products. These regulations are designed to ensure that the products that are available to consumers are safe, effective, and accurately labeled.

One of the key components of the FDA Code of Federal Regulations Title 21 is the requirement for premarket approval of drugs and medical devices. This means that before a new drug or device can be sold to the public, it must undergo rigorous testing and evaluation to ensure that it is safe and effective. This process involves submitting a new drug application or investigational device exemption to the FDA, which is reviewed by the agency to determine whether the product is suitable for sale.

In addition to the premarket approval process, the FDA Code of Federal Regulations Title 21 also includes regulations on the production and labeling of food products. These regulations cover everything from the types of ingredients that can be used in food products to the way that food products are packaged and labeled. For example, the FDA has strict guidelines on the use of additives and preservatives in food products, as well as requirements for clear and accurate labeling of ingredients and nutritional information.

Overall, the FDA Code of Federal Regulations Title 21 is an important tool for ensuring the safety and effectiveness of the products that are available to consumers. By following these regulations, manufacturers can help to protect the public and ensure that the products they produce meet the high standards of quality and safety that are expected by consumers.

• Parts 210 and 211 Drugs

• Part 820 Medical Devices

• Part 110 Food