The registration process for in vitro diagnostic (IVD) devices in the United States involves several steps, including classification, premarket notification or approval, establishment registration, and device listing with the FDA. Below is an overview of the key steps:

1. Determine the Classification of the IVD Device

• Class I, II, or III: IVD devices are classified into three categories:
  • Class I: Low-risk devices, generally subject to General Controls, such as registration, labeling, and manufacturing requirements.
  • Class II: Moderate-risk devices, typically requiring a 510(k) Premarket Notification to demonstrate substantial equivalence to a predicate device.
  • Class III: High-risk devices that typically require Premarket Approval (PMA), including clinical data to demonstrate safety and effectiveness.
• Most IVD devices fall under Class II, which requires a 510(k) submission.

2. FDA Classification and Regulatory Requirements

• Device Classification: Determine the regulatory pathway based on the device’s intended use and level of risk. For example:
  • Some IVD devices, like basic laboratory instruments, may be classified as Class I and require only general controls.
  • Class II IVD devices, such as diagnostic tests for specific diseases, generally require 510(k) clearance.
  • Class III IVD devices, such as tests for life-threatening conditions, typically require Premarket Approval (PMA).
• Risk-based Regulation: The FDA uses a risk-based approach to determine whether the device needs a 510(k), PMA, or other regulatory requirements.

3. 510(k) Premarket Notification (for Class II Devices)

• 510(k) Submission: For Class II IVD devices, manufacturers must submit a 510(k) Premarket Notification to the FDA. The 510(k) process is used to demonstrate that the device is substantially equivalent to a legally marketed device (predicate device).
  • Device Description: Include a detailed description of the device, including its intended use, technology, and materials.
  • Predicate Comparison: Provide a comparison between your device and an existing predicate device.
  • Performance Data: Include test data that demonstrates the device’s performance, including clinical or laboratory data, and any risk assessments.
  • Labeling: Provide labeling materials that comply with FDA requirements for IVD devices (e.g., instructions for use, indications, warnings, and limitations).
• 510(k) Review: The FDA typically reviews 510(k) submissions within 90 days, though this may vary depending on the complexity of the device.

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

• Premarket Approval (PMA): For Class III IVD devices, manufacturers must submit a Premarket Approval (PMA) application, which requires more extensive clinical data to demonstrate the device’s safety and effectiveness.
• Clinical Trials: PMA submissions typically involve clinical trials or substantial scientific evidence to support the claims of the IVD device.
• FDA Review: PMA applications generally take much longer to review, often 1 to 3 years.

5. Establishment Registration

• FDA Registration: All manufacturers of medical devices, including IVDs, must register their manufacturing facilities with the FDA. This registration must be updated annually through the FDA Unified Registration and Listing System (FURLS).
  • Manufacturers must provide basic information, such as the name of the company, its address, and the device types they produce.
  • Initial Registration: Registration can be completed via the FDA’s electronic registration system, and any changes in the manufacturing process or location must be reported.

6. Device Listing

• Listing: After registering the manufacturing facility, manufacturers must list all IVD devices that are intended for commercial distribution in the U.S. with the FDA. This includes providing the device name, product code, and classification.
• Annual Listing: Manufacturers are required to update their device listing annually with the FDA.

7. Labeling Requirements

• Labeling Compliance: IVD devices must meet FDA labeling requirements under 21 CFR Part 809. The labeling must include:
  • A statement of intended use
  • Instructions for use
  • Warnings and contraindications
  • Manufacturer’s name and contact information
  • Storage and handling instructions
• CLIA Waiver (if applicable): Some IVD devices may also require a CLIA (Clinical Laboratory Improvement Amendments) waiver if they are intended to be used in settings that are not subject to laboratory regulations. A waiver indicates that the device can be used by non-laboratory personnel without complex training.

8. Post-Market Surveillance and Reporting

• Medical Device Reporting (MDR): Manufacturers must establish procedures to monitor the performance of their devices once they are marketed. This includes reporting adverse events (e.g., injuries or device malfunctions) to the FDA.
• Post-Market Surveillance (if applicable): Depending on the device, manufacturers may be required to conduct post-market studies to track the device's performance in real-world settings.
• Annual Reporting: Some IVD devices may require annual reporting to the FDA to monitor their performance and any safety concerns.

9. FDA Inspections

• Facility Inspections: The FDA may conduct inspections of manufacturing facilities to ensure compliance with Good Manufacturing Practices (GMP) and other regulatory requirements. This is typically done for higher-risk devices or when there are concerns about product quality.

10. Foreign Market Considerations

• If your device is manufactured outside the United States, you will need to follow the FDA’s importation procedures, including providing the necessary import documentation and ensuring the device complies with U.S. regulations before entering the country.

Summary of Key Documents and Steps:

1. 510(k) or PMA Application (depending on the classification)
2. Establishment Registration
3. Device Listing
4. Labeling Information
5. Clinical Data (for Class III devices)
6. Risk Management Documentation
7. Post-market Surveillance and Reporting (MDR)
8. FDA Inspections (if applicable)

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