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What is the FDA certification timeline for Class I medical devices?
Category：企業(yè)動態(tài) Date：2025-01-07 17:15:14 Author: Source:
The FDA certification process for Class I medical devices typically involves the following timeline:

The FDA certification process for Class I medical devices typically involves the following timeline:

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  1. Pre-market Notification (510(k)):

    • Not required for most Class I devices: The majority of Class I devices are exempt from the 510(k) pre-market notification process, meaning they don’t need to submit a pre-market notification unless they are a combination device or fall under certain FDA exceptions.
    • 510(k) filing: For devices that do require it, the timeline for FDA review of a 510(k) submission generally takes 3 to 6 months.

  2. Registration and Listing:

    • After a Class I device is determined to be exempt from the 510(k) process (if applicable), manufacturers must still register their establishment and list the device with the FDA.
    • This is a relatively quick process and can be completed within a few weeks to a couple of months, depending on the completeness of the submission.

  3. Total Timeline:

    • For most Class I devices: If the device is exempt from the 510(k) process, FDA certification (registration and listing) can take anywhere from a few weeks to a couple of months.
    • For Class I devices requiring 510(k) submission: The total timeline could extend to around 3 to 6 months for the FDA to review and clear the submission.

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