久久窝窝国产精品午夜看片,99热成人精品,国产AV国片精品A片,欧美一级aa系列婷婷99,成一级女人大片在线视频,久久成人免费视频天天看,国产一线二线三线自拍,久久久久久久久久中文字幕,色婷婷综合久久久久中文一区二区,91亚洲精品,亚洲色欲久久久综合网,激情偷乱人成视频在线观看,亚洲 日韩成人,国产中文字幕乱人伦在线,久久私人影院香蕉,无码熟妇人妻AV在线影院,亚洲永久精品免费ww52com

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