The steps for the registration of in vitro diagnostics (IVDs) in the United States involve several key stages, depending on the device classification and regulatory pathway. Below are the general steps for IVD registration with the U.S. Food and Drug Administration (FDA):

1. Determine Device Classification

• Class I (Low Risk): These devices are subject to the least regulatory requirements and may be exempt from pre-market notification (510(k)).
• Class II (Moderate Risk): These devices typically require a 510(k) pre-market notification.
• Class III (High Risk): Devices in this category require pre-market approval (PMA), which is a more rigorous process.

2. Establishment Registration

• Step: Manufacturers must register their establishment with the FDA. This includes providing information about the manufacturing facility and the devices it produces.
• Frequency: Registration must be updated annually.

3. Device Listing

• Step: Manufacturers must list each IVD device they intend to market in the U.S. with the FDA, providing details like the device’s name, intended use, and classification.
• Frequency: This listing is also updated annually.

4. Pre-market Notification or Approval

• For Class II devices (510(k) Notification):
  • Step: Submit a 510(k) pre-market notification to the FDA to demonstrate that the device is substantially equivalent to an existing, legally marketed device.
  • Supporting Documents: Include device description, intended use, performance data, and testing results.
• For Class III devices (PMA):
  • Step: Submit a Pre-market Approval (PMA) application, providing clinical data, safety, and efficacy evidence.
  • Supporting Documents: Include clinical trial data, risk analysis, and other necessary documentation.
• For Novel Devices (De Novo Classification):
  • Step: If there is no predicate device, submit a De Novo classification request to the FDA to assign a risk-based classification.

5. Compliance with Quality Management System (QMS) Requirements

• Step: Establish and maintain a Quality Management System (QMS) in compliance with the FDA's Quality System Regulations (QSR), which includes process controls, design controls, and risk management.
• Supporting Documents: Provide evidence that the device meets these QMS standards.

6. Labeling Requirements

• Step: Ensure that the IVD meets FDA labeling requirements, including accurate and clear instructions for use, warnings, and other relevant information.
• Supporting Documents: Submit labeling documentation as part of the 510(k) or PMA submission.

7. Clinical Testing (If Required)

• Step: For Class III devices or certain Class II devices, conduct clinical trials or provide clinical data to support the device’s safety and effectiveness.
• Supporting Documents: Submit clinical trial protocols, results, and safety data.

8. FDA Review and Clearance/Approval

• Step: After submission (510(k), PMA, or De Novo), the FDA will review the documentation and may request additional information or clarification.
• Outcome:
  • 510(k): The FDA will determine whether the device is substantially equivalent to a legally marketed device.
  • PMA: The FDA will assess the clinical evidence and determine if the device is safe and effective.
  • De Novo: The FDA will classify the device into either Class I or II.

9. Post-Market Surveillance

• Step: Once the device is registered and marketed, manufacturers must comply with FDA’s post-market surveillance requirements, including monitoring adverse events and reporting issues as necessary.
• Supporting Documents: Establish a system for reporting adverse events and conducting recalls if required.

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