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The review criteria for medical device registration with the US FDA depend on the device classification (Class I, II, or III) and the type of submission (e.g., 510(k), Premarket Approval (PMA)). The main review criteria include:

1. Device Classification and Risk Assessment:

   • The FDA evaluates the device's classification based on its intended use and potential risks. This determines whether the device requires a 510(k) submission, PMA, or is exempt from premarket submission.

2. Substantial Equivalence (for 510(k) submissions):

   • For devices requiring a 510(k) submission, the FDA assesses whether the device is substantially equivalent to a legally marketed device (predicate device) in terms of safety and effectiveness.

3. Safety and Effectiveness (for PMA submissions):

   • For Class III devices requiring PMA, the FDA requires evidence of the device's safety and effectiveness, typically through clinical trials and substantial scientific data.

4. Compliance with FDA Regulations:

   • The device must comply with FDA regulations, including labeling requirements, Good Manufacturing Practices (GMP), and the Quality System Regulation (QSR) for manufacturing processes.

5. Device Labeling and Instructions for Use (IFU):

   • The FDA evaluates the device's labeling to ensure that it provides clear, accurate, and adequate information for safe and effective use, including the intended use, indications, contraindications, and risks.

6. Risk Management and Hazard Analysis:

   • The FDA reviews the manufacturer's risk management documentation, ensuring that a proper risk assessment (e.g., ISO 14971 compliance) has been conducted and that risks associated with the device are appropriately mitigated.

7. Post-Market Surveillance and Reporting:

   • The FDA examines how the manufacturer plans to monitor the device post-market, including adverse event reporting and compliance with Medical Device Reporting (MDR) requirements.

8. Clinical Data (if applicable):

   • For certain devices, the FDA may require clinical data to support claims of safety and effectiveness. This data is especially critical for PMA applications and high-risk devices.

9. Environmental Impact (for certain devices):

   • The FDA may also review environmental impact considerations, particularly for devices that could pose significant environmental risks.

10. Financial Disclosures:

• In some cases, especially for PMA submissions, manufacturers may need to disclose financial information related to clinical trials, including conflicts of interest.

The FDA uses these criteria to ensure that medical devices are safe, effective, and manufactured according to the required standards before they are allowed to be marketed in the United States.

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