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 Application Forms for FDA Certification of Medical Devices in the U.S.?
Category：企業(yè)動(dòng)態(tài) Date：2025-01-02 17:12:26 Author: Source:
The application forms required for FDA certification of medical devices in the U.S. depend on the regulatory pathway and the type of device. Here are the key forms used:

The application forms required for FDA certification of medical devices in the U.S. depend on the regulatory pathway and the type of device. Here are the key forms used:

底部圖6(1).jpg

  1. FDA Form 3514 (Premarket Approval Application - PMA):

    • This form is used for Class III devices that require Premarket Approval (PMA). It includes sections for device description, clinical data, manufacturing information, and labeling. The PMA submission involves extensive documentation to demonstrate safety and efficacy.

  2. FDA Form 2877 (Device Listing and Registration):

    • This form is used for device listing and establishment registration with the FDA. Manufacturers must complete this form to list their devices and register their establishments annually.

  3. FDA Form 510(k) (Premarket Notification):

    • This form is used for Class II devices that require 510(k) premarket notification. It provides information about the device, including its intended use, technological characteristics, and substantial equivalence to a legally marketed device.

  4. FDA Form 3674 (Certification of Compliance with Requirements of Clinical Trials):

    • For clinical trials, this form is used to certify that the device manufacturer has complied with the FDA's clinical trial regulations.

  5. FDA Form 483 (Inspectional Observations):

    • If an FDA inspection is conducted at the manufacturing site, this form may be issued to record observations or deficiencies identified during the inspection. It is not a submission form but is important for ensuring compliance during the approval process.

  6. FDA Form 3515 (Supplement to PMA Application):

    • If a manufacturer needs to make changes to a previously approved PMA device, this form is used to submit a supplement to the original application.

Contact Us：

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