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How long does it take to obtain FDA registration and certification in the United States?
Category：行業(yè)資訊 Date：2024-08-27 16:42:44 Author: Source:
These are general timelines, and the actual time can vary based on the specifics of the device and the completeness of the application.

The time it takes to obtain FDA registration and certification in the United States can vary depending on the type of medical device and the specific FDA pathway it must follow. Here are some general timelines:7(4).jpg

  1. 510(k) Premarket Notification: This process typically takes 3 to 6 months from submission to clearance, assuming there are no significant issues or requests for additional information from the FDA.

  2. Premarket Approval (PMA): For high-risk devices, the PMA process can take 6 months to several years, depending on the complexity of the device and the need for clinical data.

  3. De Novo Classification Request: This pathway is for devices that are low to moderate risk but do not have a suitable predicate device. The process usually takes 6 to 12 months.

  4. Registration and Listing: If no premarket submission is required, registration and listing can be completed in a matter of days to weeks.

These are general timelines, and the actual time can vary based on the specifics of the device and the completeness of the application.

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