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The registration process for in vitro diagnostics (IVD) in the United States involves several key steps:

1. Determine Classification: IVDs are classified into three risk categories (Class I, II, or III) based on the level of risk they pose. Most IVDs fall under Class II, which requires premarket notification (510(k)).

2. Prepare Premarket Submission: If required (for Class II or III), submit a 510(k) for FDA review or a PMA (Pre-market Approval) for Class III devices. This includes data on safety, efficacy, and performance.

3. Establish a Quality System: Ensure compliance with the FDA’s Quality System Regulation (QSR), which outlines requirements for manufacturing, design, and labeling.

4. Labeling Requirements: Provide accurate and complete labeling, including directions for use, warnings, and other regulatory information.

5. FDA Review and Approval: The FDA reviews the submission, which may involve additional testing or clarifications. If approved, you will receive FDA clearance or approval.

6. Post-Market Surveillance: Once on the market, monitor the device’s performance and report any adverse events or issues to the FDA.

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