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