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What is the typical timeline for FDA certification of medical devices?
Category：行业资讯 Date：2024-11-04 17:00:07 Author: Source:
Overall, timelines can be affected by the quality of the submission, the complexity of the device, and the FDA's current workload.

The typical timeline for FDA certification of medical devices can vary widely based on the type of submission:1.jpg

  1. 510(k) Submission: Generally takes about 3 to 6 months, but it can be longer if additional information is requested.

  2. PMA (Premarket Approval): This process is more complex and can take 6 months to several years, depending on the device's nature and the data required.

  3. De Novo Classification: Usually takes about 6 months, but similar to 510(k), it may extend if the FDA needs more information.

Overall, timelines can be affected by the quality of the submission, the complexity of the device, and the FDA's current workload.

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