高清不卡日本v二区在线,天天综合网天天综合,激情丁香五月天婷婷水蜜桃视频,91精品免费久久久久久久久,手机看片久久久久久久久,日日夜夜嫩草,日本不卡 在线视频,欧美亚洲日韩,高潮歹无毛免费观看视频,天天综合网7799日日夜夜永,欧美日本国产日韩激情视频 ,久久久无码精品亚洲日韩蜜桃,日夜夜天天人人综合网,91蜜桃长长久久,国产精品精品一区在线发布,一级a毛片免费观看久久精品

What are the fees for Class I medical device certification in the United States?
Category：企業(yè)動(dòng)態(tài) Date：2024-12-16 17:24:17 Author: Source:
For Class I medical devices in the United States, the following fees apply:

For Class I medical devices in the United States, the following fees apply:

8.jpg

  1. Establishment Registration Fee: Manufacturers and importers must pay an annual establishment registration fee to the FDA. This fee is applicable to all medical device establishments, including those involved with Class I devices.

  2. Device Listing Fee: In addition to establishment registration, manufacturers must also list their devices with the FDA. There is no specific fee for listing Class I devices, but it is required as part of the registration process.

  3. FDA User Fees: Although Class I devices are generally exempt from premarket notification (510(k)) and premarket approval (PMA), manufacturers still need to pay user fees associated with establishment registration and device listing.

The exact fees can vary each year, and manufacturers should check the FDA’s official website for the most up-to-date information on the registration fees. For Class I devices, these fees are typically lower than those for higher-risk devices (Class II and Class III).

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn