Which part of the regulations is focused on medical devices?

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The focus of the correct choice is on 21 CFR parts 800s, which specifically pertain to medical devices. This segment of the Code of Federal Regulations outlines the framework for the regulation of various medical devices, including specifications for their marketing, labeling, and manufacturing standards. It is an essential part of the regulations that ensures medical devices are safe and effective for public use before they can enter the market.

In contrast, 21 CFR parts 200s generally deal with drug regulations, including standards for pharmaceuticals and the approval process for new drugs. Meanwhile, 21 CFR parts 700s focus on cosmetics, outlining regulations that ensure consumer safety regarding cosmetic products. Finally, 21 CFR 807 specifically addresses the premarket notification (often referred to as 510(k)) process for certain categories of medical devices to demonstrate that they are substantially equivalent to devices already on the market. While 21 CFR 807 is relevant to medical devices, it is more specific in its application and not as broad as the regulations under 21 CFR parts 800s, which cover a wider range of device-related regulations.

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