The steps for registering an in vitro diagnostic (IVD) device in the United States are as follows:

1. Determine Device Classification

• The first step is to determine the classification of the IVD device based on risk and intended use. IVD devices are classified into three categories:
  • Class I (Low risk): Subject to general controls and typically exempt from premarket notification.
  • Class II (Moderate risk): Subject to general controls and special controls, requiring a 510(k) premarket notification.
  • Class III (High risk): Requires Premarket Approval (PMA), which involves more extensive testing and clinical trials.

2. Establish FDA Registration

• All medical device manufacturers, including IVD manufacturers, must register with the FDA. The registration must be done annually and includes submitting the Establishment Registration and Device Listing for each device.
• This process ensures that the FDA has knowledge of all devices being marketed in the U.S.

3. Prepare Premarket Submission

• Based on the device classification, prepare the appropriate premarket submission:
  • 510(k) Notification (for Class II devices): Submit to the FDA demonstrating that the device is substantially equivalent to an already marketed device.
  • Premarket Approval (PMA) (for Class III devices): Submit a detailed application, including clinical data and other necessary documents, for FDA review.
  • De Novo Request: If the device is novel and has no predicate device, manufacturers can request a De Novo classification to establish a new regulatory pathway.

4. Prepare and Submit Required Documentation

• Depending on the type of submission, you will need to prepare a variety of documentation, such as:
  • Labeling: Ensure that all labels and instructions for use meet FDA requirements.
  • Clinical and Non-Clinical Testing Data: Submit evidence of safety, efficacy, and performance.
  • Risk Management Documentation: Provide risk assessments and mitigation strategies.
  • Quality System Regulation (QSR) Compliance: Demonstrate compliance with the FDA’s Quality System Regulations (21 CFR Part 820) for device manufacturing processes.

5. FDA Review and Clearance/Approval

• The FDA will review the submission and may request additional information or clarification. For Class II devices, the FDA will either grant clearance (if the device is substantially equivalent to a predicate) or reject the 510(k). For Class III devices, PMA approval is required before marketing.
• The review process can take several months depending on the type of device and submission.

6. Postmarket Surveillance and Compliance

• Once the device is approved, it is essential to comply with postmarket surveillance requirements, including:
  • Adverse event reporting (e.g., MedWatch).
  • Annual registration updates.
  • Compliance with Good Manufacturing Practices (GMP).
  • Corrective actions if needed (e.g., recalls).

7. Establish Clinical Trial Requirements (if applicable)

• Some IVD devices, particularly those requiring PMA, may also require clinical trials. Clinical trials should be planned and conducted in accordance with FDA regulations.

Additional Considerations:

• Foreign Manufacturers: If the manufacturer is based outside of the U.S., they must designate a U.S. Agent for communication with the FDA.
• Quality System Requirements: Ensure compliance with the FDA’s Quality System Regulation (QSR) for the manufacture of IVD devices.

Timeline and Costs:

• Timeline: The approval process can range from a few months (for 510(k) clearance) to several years (for PMA approval), depending on the complexity of the device.
• Costs: There are FDA user fees associated with the submission process, including fees for 510(k) submissions and PMA applications.

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