The timeline for medical device registration with the US FDA depends on the type of device, its classification, and the submission process. Below are the general timelines for different types of medical device submissions:

1. 510(k) Premarket Notification (for most Class II devices)

• Timeline: Typically, the FDA takes about 3 to 6 months to review a 510(k) submission. However, this can vary depending on the complexity of the device and whether additional information or testing is requested.
• Factors Affecting Timeline: The review process can be extended if the FDA issues a refuse-to-accept (RTA) notice or requests additional data, which may delay the timeline.

2. Premarket Approval (PMA) (for most Class III devices)

• Timeline: The FDA generally takes 6 months to 1 year to review a PMA submission, but it can take longer, especially for more complex devices. For some high-risk devices, it may take several years to gather and review the necessary clinical data.
• Factors Affecting Timeline: PMA reviews are more rigorous than 510(k) reviews and typically require clinical trial data. The timeline can be extended if the FDA requests additional clinical data, clarification, or modifications to the application.

3. De Novo Classification Request

• Timeline: The FDA typically takes about 6 months to review a De Novo submission. This process is for novel devices that do not have an existing predicate and may require more detailed evidence for classification.

4. Humanitarian Device Exemption (HDE)

• Timeline: The review process for an HDE submission typically takes about 6 months. This is faster than a full PMA review and is used for devices intended to treat rare diseases affecting fewer than 8,000 people in the U.S.

5. Breakthrough Device Designation

• Timeline: For devices granted Breakthrough Device Designation, the FDA aims for expedited review. This designation allows for faster interactions with the FDA and may shorten the overall review time, but the exact timeline depends on the device’s complexity and submission completeness.

6. Priority Review

• Timeline: Priority review can shorten the review time to 6 months or less for certain devices that provide significant improvements in safety or effectiveness over existing treatments.

7. Registration of Establishment and Listing of Devices

• Timeline: The registration of an establishment (the manufacturing facility) and listing of devices with the FDA is typically a straightforward process that can take about 2 to 4 weeks if all required information is submitted correctly. This is separate from the premarket submission and typically occurs once the device has been cleared or approved.

Overall Considerations:

• Pre-Submission Meetings: Some manufacturers opt for a pre-submission meeting with the FDA to clarify requirements and potentially shorten the review process. This meeting may add several weeks to the timeline but can help ensure that the submission meets all necessary requirements.
• Additional Delays: If the FDA requests additional data or clarification, the review process can be extended. Manufacturers should factor in possible delays when planning the timeline for FDA registration.

In summary:

• 510(k) submissions: 3-6 months
• PMA submissions: 6 months to several years (depending on device complexity)
• De Novo requests: About 6 months
• HDE submissions: About 6 months
• Breakthrough/priority reviews: Expedited timelines, typically 6 months or less

It’s important to note that these are typical timeframes and can vary depending on the specifics of the device and the submission. Manufacturers should also factor in the time required for preparing the submission, including gathering necessary documentation, clinical data, and risk assessments.

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