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For companies engaged in the manufacture of medical devices, the role of regulatory consultants is vital and essential. They are the right people to deal with the regulatory affairs with the Food and Drug Administration or FDA. The FDA is the governing body that is given the full authority to regulate various products including medical devices. According to the Food, Drug and Cosmetics Act, medical devices must be regulated to ensure that the human health will not be put at risk. Thus, the Food and Drug Administration shall have the key responsibility in making sure that the medical devices presented and introduced into the market is safe and effective. Title 21 of the Code of Federal Regulations is used by the Food and Drug Administration as a basis on how they regulate medical devices. Regulatory consultants must be aware of this and study the contents of the Title 21 of the Code of Federal Regulations.