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Is FDA certification required for Class I medical devices?
Category：企業(yè)動(dòng)態(tài) Date：2025-01-07 17:17:14 Author: Source:
In the United States, FDA certification for Class I medical devices depends on the specific type of device, but in general:

In the United States, FDA certification for Class I medical devices depends on the specific type of device, but in general:

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  1. Most Class I medical devices are exempt from premarket notification (510(k)), meaning they do not require prior FDA approval before they can be marketed.

  2. However, Class I devices are still subject to FDA general controls, which include:

    Establishment Registration: Manufacturers must register their facility with the FDA.Device Listing: The device must be listed with the FDA, identifying it as a Class I device.Quality System Regulation (QSR): Manufacturers must comply with the FDA's quality system regulations, which include design controls, production, and process controls to ensure the device's safety and effectiveness.Labeling Requirements: Devices must meet FDA labeling regulations.Adverse Event Reporting: Manufacturers must report any adverse events or product defects.

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