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What is FDA certification in the United States?
Category：行业资讯 Date：2024-08-05 16:07:21 Author: Source:
​In the United States, FDA certification refers to the process by which the Food and Drug Administration (FDA) evaluates and approves medical devices before they can be legally marketed and sold in the U.S. market. The certification process ensures that medical devices meet FDA's standards for safety, effectiveness, and quality, based on their classification and intended use. Devices may undergo different pathways such as Premarket Notification (510(k)) for low to moderate-risk devices or Premarket Approval (PMA) for higher-risk devices, depending on their classification. Successful FDA certification allows manufacturers to market their devices in compliance with U.S. regulatory requirements.

In the United States, FDA certification refers to the process by which the Food and Drug Administration (FDA) evaluates and approves medical devices before they can be legally marketed and sold in the U.S. market. The certification process ensures that medical devices meet FDA's standards for safety, effectiveness, and quality, based on their classification and intended use. Devices may undergo different pathways such as Premarket Notification (510(k)) for low to moderate-risk devices or Premarket Approval (PMA) for higher-risk devices, depending on their classification. Successful FDA certification allows manufacturers to market their devices in compliance with U.S. regulatory requirements.4.jpg

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