The Regulatory Environment for Emerging Cartilage Repair Technologies
Government regulation of drugs, biologics, and devices in medicine has been established to protect patients from false claims and dangerous, unproven therapies. This protection has created hurdles for the development of new cartilage repair techniques and technologies. In the United States, the Federal Food and Drug Administration (FDA) is the body that governs the regulation of cartilage repair development. The focus of this chapter is to offer an understanding of the FDA’s history, mechanisms, and handling of cartilage technologies, as the FDA has been a standard that many industrialized nations loosely follow. As some countries recognize the shortcomings of some aspects of the FDA’s approach, they have taken innovative steps, e.g., Japan. This review sets a backdrop for the future of regulation. Understanding the nuances of the regulatory guidelines is essential during the development of new ideas, evaluation of new technologies, and progress in clinical application.
KeywordsCartilage repair FDA Orthopedics Regulation Orthobiologics
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