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

Clinical trial data is required for FDA registration and certification depending on the type of product and the submission pathway:

1. Premarket Approval (PMA):

   • Clinical Trials: Yes, clinical trial data is typically required to demonstrate the safety and effectiveness of high-risk medical devices. PMA submissions usually include extensive clinical study results.

2. 510(k) Clearance:

   • Clinical Trials: Not usually required. Instead, 510(k) submissions often rely on existing data and comparisons with legally marketed devices to demonstrate substantial equivalence. However, if substantial changes have been made to a device, clinical data may be needed.

3. De Novo Classification:

   • Clinical Trials: May be required depending on the device's risk and novelty. Clinical data helps establish the device's safety and effectiveness when there is no existing predicate device.

4. In Vitro Diagnostic Devices (IVDs):

   • Clinical Trials: Clinical data may be required to validate the device's performance and accuracy, especially for high-risk IVDs.

5. Drug-Device Combinations:

   • Clinical Trials: Clinical data is often required to support the safety and efficacy of the combined product.

In summary, clinical trial data is generally required for higher-risk devices and some novel devices but may not be necessary for lower-risk devices or those similar to existing products.