The United States Code of Federal Regulations 21 CFR, Section 820, Quality System Regulation (QSR), Current Good Manufacturing Practices (CGMP) Requirements for Medical Devices

Author(s):  
Patricia J. Zettler ◽  
Erika Lietzan

This chapter assesses the regulation of medical devices in the United States. The goal of the US regulatory framework governing medical devices is the same as the goal of the framework governing medicines. US law aims to ensure that medical devices are safe and effective for their intended uses; that they become available for patients promptly; and that manufacturers provide truthful, non-misleading, and complete information about the products. US medical device law is different from US medicines law in many ways, however, perhaps most notably because most marketed devices do not require pre-market approval. The chapter explores how the US Food and Drug Administration (FDA) seeks to accomplish its mission with respect to medical devicecough its implementation of its medical device authorities. It starts by explaining what constitutes a medical device and how the FDA classifies medical devices by risk level. The chapter then discusses how medical devices reach the market, the FDA's risk management tools, and the rules and incentives for innovation and competition. It concludes by exploring case studies of innovative medical technologies that challenge the traditional US regulatory scheme to consider the future of medical device regulation.


2020 ◽  
Vol 98 (Supplement_4) ◽  
pp. 63-64
Author(s):  
David Edwards ◽  
Charlotte Conway

Abstract In the United States, substances intended for use in animal foods are generally considered to be either animal foods or animal drugs. The regulatory classification of a substance relies on its intended use. Claims for substances that are regulated as animal foods are limited to those that can be attributed to the substance’s “food” properties, which the courts in the United States have defined as being related to the provision of nutritive value, taste, or aroma or for a technical effect on the food itself. Any substance intentionally added to an animal food must be either an approved food additive as listed in part 573 in Title 21 of the Code of Federal Regulations (21 CFR 573) or a substance that is generally recognized as safe (GRAS) for an intended use, including those listed in 21 CFR 582 and 584. Also, in coordination with state feed control officials, CVM recognizes ingredients in the Official Publication of the Association of American Feed Control Officials (AAFCO) as being acceptable for use in animal foods. Everything on a pet food label must be truthful, not misleading, and appropriate for a product regulated as food. Federal regulations (21 CFR 501) require that labels include: an appropriate product name, all ingredients in descending order of predominance by weight, a statement of net quantity of contents, and the address of manufacturer or distributor. Most states have additional labeling requirements. Studies conducted for scientific research need to be evaluated to determine if the endpoints and parameters measured are also appropriate as regulatory data. Feeding studies may address target animal safety and/or utility of the substance for its intended use as a food. CVM will provide written feedback on protocols intended to address new feed ingredients.


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