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What Are the Common Timelines and Durations for FDA Certification Applications?
Category：行業(yè)資訊 Date：2024-09-14 16:34:58 Author: Source:
Each timeline can be influenced by factors such as the completeness of the application, the complexity of the device, and the FDA’s workload.

Common timelines and durations for FDA certification applications vary by type:8.jpg

  1. 510(k) Submission: Typically takes about 90 days, but can extend if additional information is required.
  2. Premarket Approval (PMA): Generally around 180 days, though it may be longer for complex devices or additional data requests.
  3. De Novo Request: Usually around 150 days, but can vary based on the specifics of the application.

Each timeline can be influenced by factors such as the completeness of the application, the complexity of the device, and the FDA’s workload.

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