Use FDA Classification

Raiana FDA Classification is a specialized version of the Raiana chatbot for determining the likely FDA classification of a medical device and identifying potentially suitable predicate devices. Its interface is almost the same as the standard Raiana chatbot, but its purpose is different: instead of asking general regulatory questions, you describe the device that you want to evaluate.

Submit a device description

1. Enter the description of your device in the chatbot message box. Include the information needed to distinguish the device and its intended use. In this FDA Classification workflow, the description is the input for the classification and predicate-device searches; do not use this workspace as a general regulatory-question chatbot.

   

2. Submit the description by selecting the send button or pressing the Enter key. After submission, Raiana first evaluates the description against FDA classification rules and also searches more than 90,000 devices in the 510(k) database for suitable predicate devices.

Review predicate-device results

When processing is complete, review the list of 510(k) records returned by the search. These records represent the predicate devices Raiana found for the submitted device description. Use the list as the result of the 510(k) search and inspect the individual records when you need to examine a particular device or document.

To inspect a particular result, select its link in the response. Raiana opens the corresponding record in the 510(k) database so that you can immediately view that specific 510(k) document and its database information.

Review the classification result

Read the classification determination provided beneath the predicate-device results. For the example shown, Raiana determines that the device is a Class II device, and the devices listed in the accompanying table are also Class II devices for that particular case. Treat this result as the classification outcome for the submitted description and review the supporting records and context shown with it.

Use response actions and review history

The response provides Copy, Share, and Print functions for handling the displayed results. Use these functions as needed to retain or distribute the classification and predicate-device information. For detailed instructions about these common response actions, refer to the Raiana chatbot manual. FDA Classification maintains a dedicated chat history. This history contains only the devices for which you performed classification in FDA Classification, allowing you to return to previous device-classification work without mixing it with other Raiana conversations.