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Does FDA Certification for Medical Devices Really Take Up to a Year?
Category：行業(yè)資訊 Date：2024-09-14 16:34:33 Author: Source:
Overall, while the standard timelines are set, actual duration may vary based on these factors.

FDA certification for medical devices can take up to a year or more depending on several factors:1.jpg

  1. Type of Submission:

    • 510(k): Typically around 90 days, but additional information requests or complex cases can extend this.
    • Premarket Approval (PMA): Generally up to 180 days, but the process can be prolonged by the need for additional data or in-depth reviews.
    • De Novo: Usually around 150 days, though timelines can vary.

  2. Complexity of the Device: More complex devices or those requiring extensive clinical data can lengthen the review period.

  3. Quality of Submission: Incomplete or incorrect submissions can lead to delays as the FDA may request additional information or clarifications.

  4. FDA Workload: High submission volumes or backlogs can affect the review times.

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