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What is the typical review cycle for FDA medical device certification applications?
Category：行業(yè)資訊 Date：2024-09-06 17:10:04 Author: Source:
Timelines can be influenced by the completeness of the application and any additional information requested by the FDA.

The typical review cycle for FDA medical device certification applications varies based on the type of submission:4.jpg

1. 510(k) Notification

  • Standard Review Time: Generally within 90 days from the submission date.
  • Extended Review: Can be longer if additional information is requested by the FDA.

2. Premarket Approval (PMA)

  • Standard Review Time: Typically around 180 days.
  • Extended Review: May be extended based on the complexity of the device or additional data requests.

3. De Novo Classification

  • Review Time: Usually around 150 days.

4. Special Programs

  • Expedited Reviews: Programs like Breakthrough Devices may offer faster reviews, but specific timelines can vary.

Timelines can be influenced by the completeness of the application and any additional information requested by the FDA.

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