The time required to complete FDA registration and certification for a medical product depends on several factors, including the type of product, its classification, and the specific submission process. Here is a general breakdown of the timeline:

1. FDA Establishment Registration

• Timeframe: Typically a few days to a few weeks.
• This process involves registering your manufacturing facility and listing your devices with the FDA. It is a relatively straightforward process that can be completed online through the FDA's Unified Registration and Listing System (FURLS).
• Note: This registration must be updated annually.

2. 510(k) Premarket Notification (for Class II Devices)

• Timeframe: 3 to 6 months (on average).
• The 510(k) process involves submitting a premarket notification to the FDA to demonstrate that your device is substantially equivalent to an existing device on the market.
• FDA Review: After submission, the FDA typically reviews the 510(k) submission within 90 days. However, depending on the complexity of the device and the submission, this review can take longer.
• Additional Time: If the FDA requests additional information or clarification, the process may be delayed.

3. Premarket Approval (PMA) (for Class III Devices)

• Timeframe: 6 months to 2 years (or longer).
• The PMA process is more extensive and involves a thorough review of clinical data, manufacturing processes, and labeling.
• FDA Review: After submission, the FDA aims to complete the PMA review within 180 days, but it may take longer depending on the complexity of the data and device.
• Clinical Trials: If clinical trials are required, this could significantly extend the timeline, sometimes taking years depending on the nature of the trials.
• FDA Inspections: The FDA may inspect the manufacturing facility, which could add additional time to the approval process.

4. De Novo Classification Request (if no equivalent device exists)

• Timeframe: 6 months to 1 year.
• If your device is a novel product with no predicate device, you may need to submit a De Novo request to the FDA to classify your device into the appropriate risk category.
• FDA Review: The FDA typically reviews the De Novo request within 6 months, but this can vary based on the complexity of the device.

5. Post-Approval Process

After approval, there may be additional time required for labeling approval, production, and distribution setup.

Factors That Can Affect the Timeline:

• Device Complexity: More complex devices, especially Class III, will require longer review times.
• FDA Backlog: The FDA may experience delays due to high submission volumes or staffing limitations.
• Quality of Submission: Incomplete or inaccurate submissions may result in delays.
• Requests for Additional Information: If the FDA requests additional data or clarification, this can extend the timeline.

Summary of Estimated Timeframes:

• Establishment Registration: Few days to a few weeks.
• 510(k) Notification: 3 to 6 months.
• PMA: 6 months to 2 years (or longer, especially if clinical trials are required).
• De Novo Request: 6 months to 1 year.

It's important to plan ahead and allow for potential delays, especially if clinical trials or additional documentation are required.

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