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Clinical trial data is required for FDA registration and certification depending on the type of product and the submission pathway:

1. Premarket Approval (PMA):

   • Clinical Trials: Yes, clinical trial data is typically required to demonstrate the safety and effectiveness of high-risk medical devices. PMA submissions usually include extensive clinical study results.

2. 510(k) Clearance:

   • Clinical Trials: Not usually required. Instead, 510(k) submissions often rely on existing data and comparisons with legally marketed devices to demonstrate substantial equivalence. However, if substantial changes have been made to a device, clinical data may be needed.

3. De Novo Classification:

   • Clinical Trials: May be required depending on the device's risk and novelty. Clinical data helps establish the device's safety and effectiveness when there is no existing predicate device.

4. In Vitro Diagnostic Devices (IVDs):

   • Clinical Trials: Clinical data may be required to validate the device's performance and accuracy, especially for high-risk IVDs.

5. Drug-Device Combinations:

   • Clinical Trials: Clinical data is often required to support the safety and efficacy of the combined product.

In summary, clinical trial data is generally required for higher-risk devices and some novel devices but may not be necessary for lower-risk devices or those similar to existing products.