国产一区一二区高清不卡,国产一区二区最新免费视频,51日日夜夜精品视频,日日夜夜精品视频天天7799,五月伊人国语,国产一区视频,7777无码少妇一区二区三区,五月伊人国语,7799精彩视频天天看网站,国产精品无码久久久久av,永久入口,91成品人网页进入入口,欧美 日韩 中文字幕 高清,妖精视频一区二区三区亚洲,精品亚洲永久免费精品导航,久久久国产一区二区三区,天天中文综合

The regulations for the classification of medical devices in the United States are based on risk assessment and intended use. Devices are categorized into three classes:

1. Class I: Low-risk devices that do not require premarket approval. Examples include tongue depressors and elastic bandages.

2. Class II: Moderate-risk devices that require special controls to ensure safety and effectiveness. Most require a 510(k) premarket notification.

3. Class III: High-risk devices that necessitate premarket approval based on scientific evidence demonstrating safety and effectiveness.

Classification is determined by comparing a device to legally marketed devices and evaluating factors like intended use, technology, and potential risks. Regulatory requirements vary by class and include labeling, manufacturing standards, and post-market surveillance to maintain safety standards throughout the device's lifecycle.