The requirements for in vitro diagnostic (IVD) device registration in the United States are governed by the U.S. Food and Drug Administration (FDA). Below are the key requirements based on the classification of the device:

1. Device Classification

• Class I (Low Risk): Most Class I devices are exempt from premarket notification, meaning they don't require a 510(k) submission. However, they must comply with FDA’s general controls, including registration, labeling, and manufacturing standards.
• Class II (Moderate Risk): Most Class II devices require a 510(k) premarket notification to demonstrate substantial equivalence to a legally marketed device. If no substantial equivalence is found, a more detailed approval process may be required.
• Class III (High Risk): Class III devices require Premarket Approval (PMA), the most stringent FDA approval process. This includes clinical trial data to prove the safety and efficacy of the device.

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

• Substantial Equivalence: The device must be substantially equivalent to an already marketed device in terms of intended use and technological characteristics.
• Testing and Documentation: Manufacturers must provide detailed technical documentation, including performance testing, risk analysis, and labeling.
• FDA Review: The FDA reviews the 510(k) submission, which may take 3 to 6 months, but this can vary.

3. Premarket Approval (PMA) for Class III Devices

• Clinical Trials: Devices in Class III typically require clinical trial data to support their safety and effectiveness.
• FDA Review Process: The PMA process is more extensive and can take several years to complete, involving rigorous scrutiny of all submitted data.
• Manufacturing and Labeling: The FDA will also review the device’s manufacturing processes and labeling to ensure they comply with FDA regulations.

4. Quality System Regulation (QSR)

• All manufacturers must comply with the FDA’s Quality System Regulation (QSR), which outlines requirements for the design, manufacturing, and testing of IVD devices. This includes procedures for design controls, process validation, and product testing.

5. Labeling Requirements

• IVD devices must meet specific labeling requirements established by the FDA. This includes clear and accurate labeling with:
  • Intended use
  • Instructions for use
  • Performance characteristics
  • Any risks associated with the device

6. Establishment Registration and Device Listing

• Manufacturers and importers must register their establishment with the FDA and list their IVD devices.
• They must also maintain their registration annually and update device listings as necessary.

7. Postmarket Surveillance

• Adverse Event Reporting: Manufacturers must report adverse events or device-related problems through the FDA’s MedWatch system.
• Postmarket Surveillance: Ongoing monitoring and inspection by the FDA may be required to ensure the device’s continued safety and effectiveness after approval.

8. Special Pathways (if applicable)

• For some IVD devices, there may be additional regulatory pathways available, such as:
  • Emergency Use Authorization (EUA) for certain devices in public health emergencies.
  • De Novo Classification for novel devices that do not have a predicate device for comparison.

In conclusion, the requirements for IVD device registration in the U.S. depend on the device classification, intended use, and technology, with varying levels of documentation, testing, and approval processes for Class I, II, and III devices.

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