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What is the typical review timeline for FDA medical device certification applications?
Category：行業(yè)資訊 Date：2024-09-06 17:09:03 Author: Source:
Manufacturers should plan for potential delays and ensure that all required information is thoroughly prepared to facilitate a smoother review process.

The typical review timeline for FDA medical device certification applications varies depending on the type of submission. Here’s a general overview:8.jpg

1. 510(k) Notification

  • Standard Review Time: The FDA aims to review 510(k) submissions within 90 days from the date of submission.
  • Additional Time: If the FDA requests additional information or clarification, the review process can be extended. The overall timeline may therefore vary based on the completeness of the submission and any subsequent requests from the FDA.

2. Premarket Approval (PMA)

  • Standard Review Time: The FDA typically aims to complete the review of a PMA application within 180 days. This timeline includes a thorough review of the clinical data and other information provided.
  • Additional Time: Similar to the 510(k) process, the timeline can be extended if the FDA requests additional data or clarification. The complexity of the device and the completeness of the application can impact the review duration.

3. De Novo Classification Request

  • Review Time: The FDA generally aims to complete a De Novo classification request within 150 days. This is for devices that are novel and do not have a predicate device.

4. Special Programs

  • Expedited Programs: Devices that qualify for expedited review programs such as the Breakthrough Devices Program or the Humanitarian Device Exemption (HDE) may experience a faster review process. However, specific timelines can vary.

Factors Affecting Review Timelines

  • Completeness of Application: Submissions with complete and well-organized information tend to move through the review process more quickly.
  • Additional Requests: Requests for additional information or clarification from the FDA can extend the review period.
  • Device Complexity: The complexity and novelty of the device can also influence the review timeline.

Manufacturers should plan for potential delays and ensure that all required information is thoroughly prepared to facilitate a smoother review process.

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