The registration requirements for in vitro diagnostics (IVDs) in the United States depend on the device classification (Class I, II, or III). Here's an overview of the general requirements:

1. Establishment Registration and Device Listing

• Who needs to register: Manufacturers, repackagers, and relabelers of IVDs must register their establishment with the FDA.
• Device Listing: Each IVD device must be listed with the FDA, including information about the device, its intended use, and classification.
• Timeline: Establishment registration should be completed annually, and device listing must be done prior to marketing.

2. Premarket Submission

The type of premarket submission required depends on the classification of the IVD:

• Class I Devices: Most Class I IVDs are exempt from premarket notification (510(k)) requirements but must comply with general controls (e.g., establishment registration, labeling requirements). Some Class I devices are subject to specific FDA regulations.
  • Submission Required: None for most Class I devices, except for some that are subject to special controls.
• Class II Devices (510(k)): For most IVDs, a 510(k) Premarket Notification is required. This process demonstrates that the new device is substantially equivalent to an already marketed device.
  • Submission Required: 510(k) submission that includes:
    • Device description
    • Intended use
    • Performance data (e.g., analytical validation, clinical data if applicable)
    • Labeling and instructions for use
    • Risk analysis and quality system information
• Class III Devices (PMA): High-risk IVDs require Premarket Approval (PMA), which involves more comprehensive data on safety, effectiveness, and clinical trials.
  • Submission Required: PMA application including:
    • Clinical trial data (if applicable)
    • Detailed device design and manufacturing information
    • Risk management data
    • Labeling and usage instructions

3. Compliance with FDA’s Quality System Regulation (QSR)

• IVD manufacturers must establish and maintain a quality management system compliant with the FDA's Quality System Regulation (QSR) (21 CFR Part 820). This includes requirements for:
  • Design controls
  • Production and process controls
  • Corrective and preventive actions (CAPA)
  • Record-keeping and documentation

4. Labeling Requirements

• IVDs must have clear labeling that complies with FDA regulations, including:
  • Intended use
  • Directions for use
  • Warnings and precautions
  • Manufacturer’s details
  • Compliance with the FDA's labeling regulations (21 CFR Part 801)

5. Post-Market Surveillance and Reporting

• After an IVD is marketed, manufacturers must:
  • Report adverse events to the FDA (e.g., through Medical Device Reports - MDR).
  • Maintain post-market surveillance to monitor device performance and safety.

6. FDA Inspections

• The FDA may inspect the manufacturing facility to ensure compliance with QSR and other relevant regulations.
• Inspections are conducted routinely or in response to specific concerns, complaints, or incidents.

7. Special Regulatory Pathways (e.g., EUA)

• For certain situations like public health emergencies (e.g., COVID-19 diagnostic tests), IVDs may be eligible for Emergency Use Authorization (EUA).
  • Submission Required: A request for EUA, including performance data demonstrating the safety and effectiveness of the device for emergency use.

Summary of Key Documents/Information Required:

• Establishment registration
• Device listing
• 510(k) or PMA submission (depending on classification)
• Labeling and instructions for use
• Clinical or performance data (if applicable)

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