The registration requirements for in vitro diagnostics (IVDs) in the United States are governed by the U.S. Food and Drug Administration (FDA). The specific requirements depend on the classification of the device, but generally, the following steps and documents are needed:

1. Determine Device Classification:

   • IVDs are classified into three categories based on risk: Class I (low risk), Class II (moderate risk), and Class III (high risk). The classification determines the level of regulatory control required.

2. Establishment Registration and Device Listing:

   • Establishment Registration: Manufacturers must register their establishment with the FDA. This includes providing basic information about the company and its manufacturing processes.
   • Device Listing: Manufacturers must list their IVD products with the FDA, detailing the device’s name, intended use, and other key information.

3. Pre-market Notification or Approval:

   • 510(k) Notification (for Class II devices): For most Class II devices, manufacturers must submit a 510(k) pre-market notification to the FDA, demonstrating that the device is substantially equivalent to an already legally marketed device.
   • Pre-market Approval (PMA) (for Class III devices): Class III devices, which are considered high-risk, require a PMA submission. This involves providing clinical data and evidence of the device’s safety and effectiveness.
   • De Novo Classification: If a device is novel and lacks a predicate device, the manufacturer can request a De Novo classification, which provides a pathway for Class I or II designation for new devices.

4. Quality Management System (QMS):

   • Manufacturers must implement a Quality Management System that complies with the FDA’s Quality System Regulation (QSR), found in 21 CFR Part 820. This ensures that the device is designed, manufactured, and tested according to strict standards.

5. Labeling Requirements:

   • IVDs must comply with FDA’s labeling regulations (21 CFR Part 801), which include providing instructions for use, warnings, and any other relevant information to ensure proper device use.
   • Special requirements may apply to devices intended for home use, such as clear and understandable instructions for non-professional users.

6. Clinical Testing (if required):

   • Clinical studies or testing may be required, particularly for Class III devices or those that are novel. Clinical data should support the device’s safety and efficacy.
   • The FDA may also require pre-market clinical trials for certain Class II devices if they are particularly complex or new.

7. Regulatory Submission (510(k), PMA, or De Novo):

   • 510(k): For devices that are substantially equivalent to an existing, legally marketed device.
   • PMA: For Class III devices, including extensive clinical data and safety/efficacy evidence.
   • De Novo: For novel devices without a predicate, requesting a new classification.

8. Post-Market Surveillance:

   • After the device is cleared or approved, the manufacturer must comply with FDA’s post-market surveillance requirements. This includes reporting adverse events, device malfunctions, and conducting recalls if necessary.

9. Additional Requirements for Specific Types of IVDs:

   • Some IVDs, such as laboratory-developed tests (LDTs) or tests for specific diseases, may have additional or specific requirements under FDA guidance.

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