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

How are medical devices classified in the United States?
Category：企業(yè)動(dòng)態(tài) Date：2024-12-25 17:23:22 Author: Source:
In the United States, medical devices are classified into three categories based on their risk level and the level of regulatory control required by the FDA. These classifications are:

In the United States, medical devices are classified into three categories based on their risk level and the level of regulatory control required by the FDA. These classifications are:

底部圖7.jpg

  1. Class I:

    • Low risk devices that generally do not require premarket approval.
    • Most Class I devices are exempt from premarket notification (510(k)) and only need to comply with general controls, such as labeling requirements and good manufacturing practices (GMP).
    • Examples: Bandages, stethoscopes, tongue depressors.

  2. Class II:

    • Moderate risk devices that require premarket notification through the 510(k) process, where manufacturers demonstrate that the device is substantially equivalent to a legally marketed device.
    • Class II devices must meet specific performance standards and post-market surveillance requirements.
    • Examples: Infusion pumps, blood pressure cuffs, surgical drapes.

  3. Class III:

    • High risk devices that require Premarket Approval (PMA), a more rigorous process that includes clinical trials and comprehensive data to demonstrate the device's safety and efficacy.
    • Class III devices are typically life-supporting or life-sustaining, or they present a significant risk of injury or illness.
    • Examples: Pacemakers, artificial heart valves, neurostimulators.

Contact Us：

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