The conditions for the registration of in vitro diagnostics (IVDs) in the United States are set by the U.S. Food and Drug Administration (FDA). The specific conditions depend on the device's classification, intended use, and regulatory pathway. Below are the general conditions for IVD registration:

1. Device Classification:

   • Class I (Low Risk): IVDs classified as Class I are subject to the least regulatory control. Many Class I devices are exempt from pre-market notification (510(k)) but must still comply with general FDA requirements, including establishment registration, device listing, and compliance with labeling and quality system regulations.
   • Class II (Moderate Risk): Most IVDs fall under Class II. These devices require a pre-market notification (510(k)) submission to demonstrate substantial equivalence to a legally marketed device.
   • Class III (High Risk): IVDs classified as Class III require a pre-market approval (PMA), which involves submitting extensive clinical data and other evidence to prove the device's safety and effectiveness.

2. Establishment Registration:

   • Manufacturers must register their establishment with the FDA, providing basic information about their manufacturing operations.
   • The registration must be updated annually.

3. Device Listing:

   • Manufacturers must list each IVD device they intend to market in the United States with the FDA.
   • The listing includes details about the device, such as its intended use, classification, and other necessary information.

4. Pre-market Notification or Approval:

   • 510(k) Notification: Most Class II devices require the manufacturer to submit a 510(k) pre-market notification to demonstrate that the device is substantially equivalent to an existing legally marketed device.
   • Pre-market Approval (PMA): Class III devices require pre-market approval, which is a more rigorous process involving clinical trials and a comprehensive review of safety and efficacy data.
   • De Novo Classification: For novel devices with no predicate, manufacturers can apply for a De Novo classification, which involves a risk-based review to assign the device to Class I or II.

5. Quality Management System (QMS):

   • Manufacturers must establish and maintain a quality management system compliant with the FDA's Quality System Regulations (QSR) (21 CFR Part 820). The system ensures that the device is consistently produced and controlled according to quality standards.

6. Labeling Requirements:

   • Devices must meet FDA labeling regulations (21 CFR Part 801), which include clear and accurate instructions for use, warnings, and other relevant information.
   • For IVDs, labeling must provide accurate details about the test's purpose, how to use the device, and interpretation of results.

7. Clinical Data (if required):

   • For Class III devices or some Class II devices, manufacturers must submit clinical trial data to demonstrate the safety and effectiveness of the device.
   • The FDA may also require clinical studies or performance data for certain IVDs, even if they fall under Class II.

8. Post-Market Surveillance and Reporting:

   • After the device is registered and marketed, manufacturers must adhere to FDA post-market surveillance requirements, which include monitoring and reporting adverse events, device failures, and implementing recalls if necessary.

9. Specific Conditions for Laboratory-Developed Tests (LDTs):

   • Some IVDs, such as laboratory-developed tests, may have additional regulatory conditions under FDA guidance or may be subject to different requirements depending on the intended use and level of risk.

10. Compliance with Additional FDA Guidelines:

    • Manufacturers must also ensure compliance with any applicable FDA guidance documents, special controls, and additional requirements based on the type of IVD.

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