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What is the typical review timeline for FDA medical device certification applications?
Category：行業(yè)資訊 Date：2024-08-30 17:10:22 Author: Source:
FDA Performance Goals: The FDA has performance goals for review times under certain user fee programs, which can help provide more predictable timelines.

The typical review timeline for FDA medical device certification applications varies depending on the type of submission:1.jpg

1. 510(k) Notification

  • Review Timeline: Usually 3 to 6 months.
    • Factors Affecting Timeline: The complexity of the device, completeness of the submission, and whether additional information or clarification is required can influence the review time.

2. Premarket Approval (PMA)

  • Review Timeline: Generally 6 to 12 months.
    • Factors Affecting Timeline: The complexity of the device, the quality of clinical trial data, and the need for additional information or inspections can impact the review duration.

3. De Novo Classification

  • Review Timeline: Typically 6 to 12 months.
    • Factors Affecting Timeline: The novelty of the device, completeness of the submission, and whether additional information or clarification is needed can affect the review time.

Additional Notes

  • Expedited Programs: Certain programs like Breakthrough Devices or Fast Track may offer expedited review timelines for devices that address unmet medical needs or provide significant benefits over existing treatments.
  • FDA Performance Goals: The FDA has performance goals for review times under certain user fee programs, which can help provide more predictable timelines.

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