The registration timeline for in vitro diagnostic (IVD) devices in the United States can vary depending on the device's classification, the regulatory pathway required (e.g., 510(k) premarket notification or Premarket Approval), and the complexity of the device. Below is an overview of the typical timelines for each step in the process:

1. 510(k) Premarket Notification (Class II IVD Devices)

• Preparation Time: The preparation of a 510(k) submission can take several months, depending on the device's complexity and the availability of required data (e.g., performance, clinical, or laboratory test data). The time to prepare the documentation can vary, but it typically takes between 3 to 12 months.
• FDA Review Time: Once the 510(k) submission is complete, the FDA generally takes 90 days to review the application. However, this timeline may extend if additional information or clarification is requested by the FDA. In some cases, the review can take up to 120 days or longer.
• Total Timeline for 510(k): The entire process, from preparation to FDA clearance, generally takes 6 months to 1 year, depending on the complexity of the device and the review process.

2. Premarket Approval (PMA) (Class III IVD Devices)

• Preparation Time: For Class III IVD devices, which require Premarket Approval (PMA), the preparation of the application can take significantly longer due to the extensive clinical data and other evidence required. The preparation process can take anywhere from 12 months to several years, depending on the device's complexity and the need for clinical trials.
• FDA Review Time: Once the PMA application is submitted, the FDA typically takes 180 days to complete its initial review, although this timeline can be extended if the FDA requests additional information. For more complex devices, or those that require additional studies, the review time may be longer, sometimes taking up to 1 to 3 years.
• Total Timeline for PMA: The entire process, from preparation to approval, typically takes 1 to 3 years. This can vary significantly depending on the nature of the device and the extent of clinical evidence required.

3. Establishment Registration and Device Listing

• Registration Process: The establishment registration process is typically straightforward and can usually be completed within a few weeks. Manufacturers must register their facility with the FDA and list their IVD devices before they can be marketed.
• Device Listing: Device listing is often done concurrently with registration, and it typically takes a few days to complete. However, manufacturers are required to update the listing annually.

4. Labeling and Documentation

• Labeling Compliance: Preparing labeling and related documentation can take anywhere from a few weeks to a few months, depending on the complexity of the device and the labeling requirements (e.g., CLIA waivers, user instructions, warnings, etc.).

5. FDA Inspections (if applicable)

• Inspection Process: If the FDA conducts a manufacturing facility inspection, the timeline for this can vary. Inspections are typically scheduled after a 510(k) or PMA application has been submitted, and the process can take several weeks to a few months depending on the availability of the FDA and the manufacturer’s readiness for inspection.

Summary Timeline for IVD Device Registration:

1. 510(k) Submission (Class II):

   • Preparation: 3 to 12 months
   • FDA Review: 90 to 120 days
   • Total Time: 6 months to 1 year

2. PMA Submission (Class III):

   • Preparation: 12 months to several years
   • FDA Review: 180 days to 1-3 years
   • Total Time: 1 to 3 years

3. Establishment Registration and Device Listing:

   • Time: A few weeks to a few days

4. Labeling and Documentation:

   • Time: A few weeks to a few months

5. FDA Inspection (if applicable):

   • Time: Several weeks to a few months

Conclusion:

The overall registration timeline for IVD devices in the U.S. can vary widely based on the device’s classification, the regulatory pathway required, and the complexity of the data involved. For Class II devices, the process typically takes about 6 months to 1 year, while for Class III devices, the process may take 1 to 3 years or more.

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